| CTRI Number |
CTRI/2023/04/052030 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry Other (Specify) [Bone graft Evaluation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Socket preservation by Bone graft placement |
|
Scientific Title of Study
|
Comparison of Bone Mineral Density and Primary Implant Stability after Socket Preservation by Calcium Phospho-silicate Putty, Sticky Bone and Natural Bone Healing: A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kshipra Kawadkar |
| Designation |
Post Graduate Student |
| Affiliation |
VYWS Dental College and Hospital |
| Address |
Kawadkar hospital, 6, 7 tantra nagar, nandura road , khamgaon-444303. Kawadkar hospital Amravati MAHARASHTRA 444303 India |
| Phone |
09404693955 |
| Fax |
|
| Email |
kshipra.kawadkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Simran Parwani |
| Designation |
HOD and Professor department of periodontology |
| Affiliation |
VYWS Dental College and Hospital |
| Address |
Tapovan wadali road, camp road, SRPF colony, amravati
Amravati MAHARASHTRA 444602 India |
| Phone |
9977132697 |
| Fax |
|
| Email |
simpar74@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kshipra Kawadkar |
| Designation |
Post Graduate Student |
| Affiliation |
VYWS Dental College and Hospital |
| Address |
Kawadkar hospital, 6, 7 tantra nagar, nandura road , khamgaon-444303. Kawadkar hospital Amravati MAHARASHTRA 444303 India |
| Phone |
09404693955 |
| Fax |
|
| Email |
kshipra.kawadkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| VYWS Dental College And Hospital, Amravati |
|
|
Primary Sponsor
|
| Name |
Dr Kshipra P Kawadkar |
| Address |
VYWS Dental College and Hospital, amravati-444602 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KSHIPRA |
Department of Periodontology |
Department no 16, PG section room,1st floor,VYWS, Dental College and Hospital, Amravati. Amravati MAHARASHTRA |
9404693955
kshipra.kawadkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-VYWSDCHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NATURAL HEALING SOCKETS |
to evaluate bone mineral density and primary implant stability at the time of implant placement in sockets preserved with natural healing without adding bone graft after 4 months of extraction |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NOVABONE PUTTY |
to evaluate after 4 months efficay of using novabone putty in socket prerservation to evaluate bone mineral density and primary implant stability at the time of implant placement |
| Intervention |
STICKY BONE |
To evaluate after 4 months of socket preservation after extraction by sticky bone with help of CBCT by Bone Mineral Density and primary implant stability at the time of implant placement . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants in the age range of 18 to 50 years
2)Participants having good oral hygiene
3)Presence of tooth or root piece indicated for extraction
4)Participant’s willingness for implant placement
5)Loe and Silness Gingival index less than or equal to 1
|
|
| ExclusionCriteria |
| Details |
1) Acute infection.
2) Medically compromised patients.
3) Uncooperative patients.
4) Non-compliant patients for oral hygiene maintenance
5) Subjects with abnormal bleeding/clotting time
6) Presence of periodontal pockets
7) History Of Irradiation in Head and Neck
8) Uncontrolled diabetic patients (reported levels of glycemia over the normal threshold)
9) Current pregnancy or lactation
10) Current Smokers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the differences in bone mineral density by Lekholm and Zarb (1985) classification on CBCT.
2. Primary stability of implants after four months of socket preservation by nova-bone putty and sticky bone compared to spontaneous/ natural healing.
|
4 months after graft placement in socket the implant placement and bone density will be evaluated
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
Target Sample Size
|
Total Sample Size="27" Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet as trial is in initial stages |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Socket preservation is a procedure which preserves the hard as well as soft tissues of the alveolar ridge after tooth extraction. 40% bone height reduction and 60% bone width reduction occur after 6 months of extraction. Bone loss occurs more on labial surface rather than lingual or palatal surface.This alveolar ridge resorption makes it difficult or next to impossible for fabrication of implant supported prosthesis. Thakkar et al. conducted a clinical study to evaluate bone healing and soft tissue alterations after removal of teeth. The authors found that after 12 months 50% of buccolingual width of edentulous site was lost. They concluded that preservation of bone in that area is mandatory specifically if osseo-integrated implants are to be planned. Various studies have shown positive impact of using different grafts, membranes and growth factors to preserve the sockets compared to spontaneous healing. Primary implant stability is a prerequisite for a predictable, long term secondary stability (Osseo-integration), the success of secondary stability depends upon the bone quality and quantity at the receptor site. The term ‘‘bone quality’’ is not clearly defined in the literature. This includes physiological and structural aspects and the degree of bone tissue mineralization. The present study is aimed to investigate bone mineral density (by Lekholm and Zarb classification, 1985), on Cone Beam Computed Tomography [CBCT] and primary implant stability (by Insertion Torque Value [ITV]) after three months of socket preservation with: Nova bone putty (Group A); Sticky bone (Group B) as compared to spontaneous healing (Group C). |