ARMY DENTAL CENTRE (RESEARCH AND REFERRAL)

ARMY HOSPITAL (RESEARCH AND REFERRAL)

DELHI CANTT- 110010

 

THESIS PROTOCOL

FOR

MDS – PERIODONTOLOGY

(2023-2026)

 

 

COMPARATIVE CLINICAL, RADIOLOGICAL & HISTOLOGICAL EVALUATION OF AUTOGENOUS PARTICULATE DENTIN GRAFT VS ALLOGRAFT FOR SOCKET PRESERVATION:

A RANDOMIZED CLINICAL TRIAL

 

 

Under the guidance of

POSTGRADUATE GUIDE

 

 

COL (DR) T PRASANTH

PROFESSOR

DEPARTMENT OF PERIODONTOLOGY

ARMY DENTAL CENTRE (RESEARCH AND REFERRAL)

DELHI CANTT-110010

 

 

 

 

Name of the student

 

LT COL (DR) MANISH GUPTA

PG RESIDENT

DEPARTMENT OF PERIODONTOLOGY

 

CERTIFICATE

 

I certify that the facilities for the work on the subject of the thesis: Comparative Clinical, Radiological and Histological Evaluation of Autogenous Particulate Dentin graft Vs Allograft for Socket Preservation: A Randomized Clinical Trial does exist in this department and Army Hospital (R&R) and will be provided to the candidate. I shall see that the data being included in the thesis is genuine and the candidate himself does the work.

 

 

 

 

 

 

 

 

 

Date:                                                                          Col (Dr) T Prasanth

                                                                                MDS (Periodontology)

                                                                                Professor

                                                                                Department of Periodontology

                                                                                Army Dental Centre (R&R)

                                                                                Delhi Cantt - 110010

                                                                                                   

 

 

 

 

 

 

 

 

 

 

 

 

 

Remarks of the PG Guide

 

Recommended and forwarded for approval of the above protocol

 

 

 

 

Date:                                                                          Col (Dr) T Prasanth

                                                                                MDS (Periodontology)

                                                                                Professor

                                                                                Department of Periodontology

                                                                                Army Dental Centre (R&R)

                                                                                Delhi Cantt – 110010

 

 

 

 

 

 

Date:                                                                             Brig (Dr) AK Shreehari

                                                                                      MDS (Periodontology)

                                                                                      Associate Professor &

                                                                                      Co-supervisor

                                                                                      Department of Periodontology

                                                                                      Army Dental Centre (R&R)

                                                                                      Delhi Cantt – 110010

 

 

 

                                                                           

Remarks of the University Cell and Dean Academics

 

Recommended and forwarded for approval of the above protocol

 

 

 

Date:                                                                          Dean Academics

                                                                                Army Hospital (R&R)

                                                                                Delhi Cantt - 110010

 

 

 

ARMY DENTAL CENTRE (RESEARCH AND REFERRAL), DELHI CANTT

CERTIFICATE FROM ETHICAL COMMITTEE REVIEWERS

 

Name of Officer: Lt Col Manish Gupta

 

                   Title: Comparative Clinical, Radiological and Histological Evaluation of 

                            Autogenous Particulate Dentin graft Vs Allograft for Socket    

                            Preservation: A Randomized Clinical Trial

 

SIGNATURES OF ETHICAL COMMITTEE MEMBERS

 

 

Chairperson                      :          _________________________________________

                                      (Col Nilav Bhagabati)

                                                  HOD, Dept of Conservative & Endodontics Dentistry

 

Vice Chairperson               :          _________________________________________

                                                  (Col T Prasanth)

                                                  HOD, Dept of Periodontics

 

Member Secretary             :          _________________________________________

                                                  (Lt Col Kanaram Choudhary)

                                                  Training Officer

 

Basic Medical Scientist      :          _________________________________________    

                                      (Dr MK Semwal)

                                                  Scientist ‘G’ (DRDO)

 

Two Clinicians                   :          _________________________________________

                                                  (Lt Col Saravanan SP)

                                                  Dept of Periodontics

 

                                        :          _________________________________________

                                                  (Maj Dhruv Jain)

                                                  Dept of Orthodontics

 

Legal Expert                     :          _________________________________________

                                                  (Mr Veerendra Mohan)

 

Social Psychologist            :          _________________________________________

                                                  (Dr Sarbani Chowdhury)

 

Educationist                      :          _________________________________________

                                                  (Mrs Beena Prasanth)

 

 

COUNTERSIGNATURE OF COMDT

 

 

Place :Delhi Cantt-10                                                            (Sukhbir Singh Chopra)

                                                                                          Brig

Date :                                                                                 Comdt

 

 

 

 

 

 

 

 

 

COMPARATIVE CLINICAL, RADIOLOGICAL & HISTOLOGICAL EVALUATION OF AUTOGENOUS PARTICULATE DENTIN GRAFT VS ALLOGRAFT FOR SOCKET PRESERVATION:

 A RANDOMIZED CLINICAL TRIAL

 

 

 

CONTENTS

		Page No
INTRODUCTION		1-2
REVIEW OF LITERATURE		3-4
AIM AND OBJECTIVES OF RESEARCH		5
MATERIALS AND METHODS		6-8
REFERENCES		9-10

             

INTRODUCTION

            

 

           Tooth extraction is one of the routine outpatient procedures done universally as a treatment plan of hopeless tooth. After tooth extraction dimensional change in the alveolar ridge is inevitable. The extraction socket heals from the apex toward the crest. When no substitute materials are placed into the socket at the time of the extraction, the soft tissue infiltration at the crest often results in facial and crestal bone loss.

           This bone resorption is more rapid in case of pre-existing periodontal disease, inflammatory periapical lesions or serious previous bone wall defects due to traumatic extraction. The greatest amount of bone loss is in the horizontal dimension and occurs mainly on the facial aspect of the ridge. There is also loss of vertical ridge height, which has been described to be most pronounced on the buccal aspect (Lekovic et al. 1997, 1998, Araujo & Lindhe 2005). This resorption process results in a narrower and shorter ridge and the effect of this resorptive pattern is the relocation of the ridge to a more palatal/lingual position (Pinho et al. 2006). Therefore preserving the alveolar dimension of the socket after extraction is mandatory for future rehabilitation such as fixed partial denture, dental implants. Socket preservation is a surgical procedure in which bone substitute material or a scaffold is placed in a fresh extraction socket to prevent alveolar ridge resorption.

             Teeth and bones share many similarities. Teeth, cartilages, nerves, and maxillofacial bones all embryologically originated in the neural crest, sharing identical origin. Based on the potentials of osteoconduction, osteoinduction, and osteogenesis through growth factors in tooth and similar histogenesis between tooth and bone, a novel bone substitute material can be developed utilizing the inorganic and organic components of an extracted tooth (Cetiner Y et al 2021)

           Indeed, autogenous tooth bone graft material has been developed from an extracted tooth. There are many techniques, like using autogenous, allogeneic, xenograft, and alloplast graft materials, to guide and assist specialized cellular components of the periodontium to participate in the regenerative process to preserve bone width and height of the alveolus.

         This study aims to compare clinical, radiological and histological evaluation of autogenous particulate dentin graft vs allograft (Demineralized freeze – dried bone allograft) for socket preservation.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   

                                 REVIEW OF LITERATURE

       Reduction in the alveolar bone dimensions invariably occurs after tooth extraction. During socket healing period, new bone grows into the extraction site while the alveolar ridge is being resorbed. Several studies have demonstrated that the width and the height of the alveolar bone decreased significantly immediately after tooth extraction Lam RV (1960)¹& Pietrokovski J, Massler M (1967)². Dimensional loss of socket bone hinders dental implant placement and conventional prosthesis. Therefore, in order to maintain the alveolar ridge dimensions, it is essential to perform socket preservation procedures after tooth extraction, which can be performed by placement of grafting materials in the extraction socket as a framework for bone deposition.

        Studies by Lekovic et al (1997,1998)^3,4 have shown that treatment of extraction sockets with membranes is valuable in preserving alveolar bone in extraction sockets and preventing alveolar ridge defect.

        Lee et al (2011)⁵ compared the efficiency of autogenous demineralized Dentin Matrix (ADDM) and other bone graft materials used in sinus bone graft surgeries; after four 4 months of healing, there was favorable bone formation, but ADDM revealed faster rate of resorption and superior quality of bone formation.

        Park et al (2012)⁶ demonstrated that auto-tooth bone graft material exhibited osteoconduction and osteoinduction properties and can be considered as a replacement to autogenous bone.

        Kim et al (2014)⁷ evaluated the clinical efficacy of autogenous tooth bone graft material  in alveolar ridge preservation of an extraction socket on thirteen patients who received extraction socket graft using ADDM followed by delayed implant placement and concluded that ADDM can be considered as a favorable bone substitute for extraction socket graft due to its bone remodeling and osteoconductive properties.

       Binderman et al (2014)⁸ demonstrated that autogenous mineralized dentin particles can be employed as bone grafts for socket preservation, bone augmentation in sinus and bone defects by preparing freshly extracted teeth into a bacteria free dentin graft and grafting them immediately into extraction sites and bone deficiencies followed by successful placement of implants.

       Guiradoa et al (2018)⁹ based on experimental studies concluded that autogenous dentin particulate graft in post extractions socket  may be considered as a useful biomaterial for socket preservation , protecting both buccal and lingual plates, generating large amounts of new woven bone formation after 60 days, and small amounts of lamellar bone after 90 days of healing

     Smith RB, Tarnow DP (2013)¹⁰ describes extraction sockets based upon the bone available within the socket for stabilization of an immediately placed implant for molar extraction sites as

(i)              Type A socket which allows for the implant to be placed completely within the septal bone, leaving no gaps between the implant and the socket walls

(ii)              Type B socket which has enough septal bone to stabilize but not completely surround the implant, leaving gaps between one or more surfaces of the implant and the socket walls.

(iii)           Type C socket which has little to no septal bone, thus requiring that the implant engage the periphery of the socket.

     The advantages of autogenous dentin graft over xenogeneic or alloplastic bone graft   substitution are; Low graft rejection and Osteoinductivity due to presence of Bone morphogenetic proteins (BMPs), Transforming growth factor-beta (TGF-β),and Insulin-like growth factor -1 and -2 (IGF-1 and-2) .

               

      With this background the present study aims to compare the clinical, radiological, histological evaluation of autogenous particulate dentin graft vs allograft (DFDBA) for socket preservation in Type A extraction socket of mandibular posterior teeth.

AIM AND OBJECTIVES

 

 

 

AIM:

         

           To compare the clinical, radiological, histological outcomes of autogenous

           particulate dentin graft vs allograft (Demineralized freeze – dried bone allograft)  

           for socket preservation in Type A extraction socket.

 

OBJECTIVES:

 

1.     To clinically assess the changes in bucco-lingual width of socket at crestal lines

2.     To radiographically assess the change in bucco-lingual width of the edentulous area at the crestal level pre and post surgically using Cone-beam computed tomography (CBCT).

3.     To radiographically assess the change in bucco-lingual width of the edentulous area at the mid buccal level pre and post surgically using CBCT.

4.     To radiographically assess the change in height of edentulous area pre and post surgically using CBCT.

5.     To histologically assess the new bone formation at 6 months post socket preservation.

           

 

 

 

 

 

 

 

 

 

 

 

 

MATERIALS AND METHODS

 

·       Type of Study – Interventional study- Randomized controlled clinical trial with Parallel arm design

 

·       Source of data-Subjects visiting Dept. of Periodontology of a tertiary care teaching institution.                         

 

·       Sample size - To test for one tailed hypothesis about mean as per reference article(El-Said Marwan M., et al. 2017) to   Buccal/Lingual width changes after socket preservation , the Mean ±S.D : 0.45±0.14 with following parameter below:

 

(Level of confidence)  α = 0.05 

                     (Power)  β = 80%

                                    Âµ₀ = 0.32

                                    Âµ₁ = 0.45

           Std deviation(S.D)=0.14

               Sample size (n)= 9

and considering 10 % dropouts the final sample was calculated as 10/group (Total =20)

             Above Sample Size was calculated using the  formula n =

 

       Inclusion criteria:

 

      1.Patients aged between 20 and 50 years.

      2.Systemically healthy patients.

      3.Patients who have indication for dental extraction in mandibular posteriors          

      4.Post extraction socket classification of Type A (Smith and Tarnow 2013)

 

 

 

       Exclusion criteria:

 

     1.Patient exhibiting with periapical infection in tooth planned for socket preservation.

     2. Mandibular third molar to be excluded

     3.Pregnant and lactating women.

     4.Smokers (Current/Past)

     5.Patients with known documented allergy to DFDBA, Sodium Hydroxide

     6.Patients with Full mouth Plaque Score ≥ 20 % after phase I therapy.

 

 

STUDY PROTOCOL

 

1.     Institutional Ethical clearance (IEC) will be obtained from the Institution Ethical Committee. After obtaining IEC approval the Study will be registered with clinical trial registration of India. A bilingual informed consent will be obtained from all the subjects enrolled for the study. Clinical examination will be proceeded by complete dental and medical history. Radiographic evaluation (IOPAR) of selected edentulous region. A total of 20 Subjects will be selected for the study and divided in to two groups randomly by block randomization using computer generated table of random numbers.

2.     Clinical photographs & study models  will be prepared and Phase 1 therapy will be carried out. Pre surgical preparation such as stent will be prepared for clinically evaluation of socket width .Modified plaque index will be calculated for each subject prior to surgical procedure. Atraumatic extraction for both groups Cone beam computed tomography (CBCT) evaluation of the selected edentulous  region to determine,

           a)  Bucco-Lingual width of the edentulous area at crestal level

           b)  Bucco-Lingual width of the edentulous area at mid buccal level

           c) Height of edentulous area

           Clinical evaluation of socket width will be recorded, immediately after extraction

          (Day 0) by using bone caliper and prefabricated custom made acrylic stent.

      Autogenous dentin graft will be prepared using dentin grinder and will be placed  

      in the extracted socket for Group 1 and DFDBA will be placed in Group 2,   

      Primary closure of socket with suture after the placement of collagen     

      membrane.

3.     Clinical re-evaluation will be at the end of 3 months and 6 Months. CBCT re-evaluation will be at the end of 6 months. Histological evaluation will be at the end of 6 months at the time of implant placement to evaluate the new bone  formation.

                

 

 

                   Appropriate statistical test will be applied to compare the both groups to

          compare the clinical, radiological, histological outcomes of autogenous   

          particulate dentin graft vs allograft (DFDBA) for socket preservation.

                                                         

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REFERENCES

 

1.     Lam RV. Contour changes of the alveolar processes following extractions. The

Journal of prosthetic dentistry. 1960 Jan 1;10(1):25-32.

2.     Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. The Journal of prosthetic dentistry. 1967 Jan 1;17(1):21-7.

3.     Lekovic V, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. Journal of periodontology. 1997 Kenney EB, Jun;68(6):563-70.

4.     Lekovic V, Camargo PM, Klokkevold P, et al. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol 1998;69:1044–1049

5.     Lee JY, Kim YK, Kim SG, Lim SC. Histomorphometric study of sinus bone graft using various graft material. Journal of Dental Rehabilitation and Applied Science. 2011;27(2):141-7.

6.     Park SM, Um IW, Kim YK, Kim KW. Clinical application of auto-tooth bone graft material. Journal of the Korean Association of Oral and Maxillofacial Surgeons. 2012 Feb 1;38(1):2-8

7.     Kim YK, Yun PY, Um IW, Lee HJ, Yi YJ, Bae JH, Lee J. Alveolar ridge preservation of an extraction socket using autogenous tooth bone graft material for implant site development: prospective case series. The journal of advanced prosthodontics. 2014 Dec 1;6(6):521-7.

8.     Binderman I, Hallel G, Nardy C, Yaffe A, Sapoznikov L. A novel procedure to process extracted teeth for immediate grafting of autogenous dentin. J Interdiscipl Med Dent Sci. 2014 Oct;2(154):2.

9.     Calvo-Guirado JL, Cegarra Del Pino P, Sapoznikov L, Delgado Ruiz RA, Fernández-Domínguez M, Gehrke SA. A new procedure for processing extracted teeth for immediate grafting in post-extraction sockets. An experimental study in American Fox Hound dogs. Ann Anat. 2018 May;217:14-23. doi: 10.1016/j.aanat.2017.12.010. PMID: 29454891.

10. Smith RB, Tarnow DP. Classification of molar extraction sites for immediate dental implant placement. International Journal of Oral & Maxillofacial Implants. 2013 Jun 1;28(3).

11. El-Said MM, Sharara AA, Melek LF, Khalil NM. Evaluation of autogenous fresh demineralized tooth graft prepared at chairside for dental implant (clinical and histological study). Alexandria Dental Journal. 2017 Apr 1;42(1):47-55.