| CTRI Number |
CTRI/2023/08/056791 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enamel Matrix Derivative and Demineralized Freeze-Dried Bone Allograft in treatment of Class II furcation defect |
|
Scientific Title of Study
|
Comparative Evaluation of Enamel Matrix Derivative and Demineralized Freeze-Dried Bone Allograft in the treatment of Class II furcation defects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ria Sahay |
| Designation |
PG Resident |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareilly road, Utrathia, Lucknow, Uttar Pradesh 226029
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
8580006039 |
| Fax |
|
| Email |
riasahay2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitabh Srivastava |
| Designation |
Professor and Head of Department |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Professor and Head Department of Periodontology Sardar Patel Postgraduate Institute Of Dental And Medical Sciences, Utrathia, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
9415085343 |
| Fax |
|
| Email |
docamitabh74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ria Sahay |
| Designation |
PG Resident |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareilly road, Utrathia, Lucknow, Uttar Pradesh 226029
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
8580006039 |
| Fax |
|
| Email |
riasahay2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, SPPGIDMS, Lucknow |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Raebareilly road, Utrathia, Lucknow, Uttar Pradesh-226029 |
| 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 Ria Sahay |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
Room no.7, Department of Periodontology
Lucknow
UTTAR PRADESH |
8580006039
riasahay2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Demineralized Freeze-Dried Bone Allograft |
Extra oral antisepsis and intra oral antisepsis will be performed with 5% povidone iodine solution and 0.2% chlorhexidine digluconate mouth rinse respectively. The operative site will be anaesthetized with 2% Lignocaine HCl with adrenaline (1:80,000) using block and infiltration techniques, following which an intrasulcular incision will be made around the involved tooth and extending to the adjacent tooth for adequate access. Full thickness mucoperiosteal flap will be reflected to access the underlying bone morphology in furcation defect area. The area will be properly debrided using Gracey curettes and with ultrasonic device. The root surfaces of defect will be conditioned using 24% EDTA gel for 2 min, followed by thorough rinsing with sterile saline solution. with sterile saline, DFDBA is mixed in a sterile dappen dish and the graft material will be packed in the defect to the most coronal level of surrounding bony walls using amalgam condenser and membrane will be adapted to the defect. Patients will be recalled at 1, 3, and 6 months |
| Intervention |
Enamel Matrix Derivative |
Extra oral antisepsis and intra oral antisepsis will be performed with 5% povidone iodine solution and 0.2% chlorhexidine digluconate mouth rinse respectively. The operative site will be anaesthetized with 2% Lignocaine HCl with adrenaline (1:80,000) using block and infiltration techniques, following which an intrasulcular incision will be made around the involved tooth and extending to the adjacent tooth for adequate access. Full thickness mucoperiosteal flap will be reflected to access the underlying bone morphology in furcation defect area. The area will be properly debrided using Gracey curettes and with ultrasonic device. The root surfaces of defect will be conditioned using 24% EDTA gel for 2 min, followed by thorough rinsing with sterile saline solution. Excess fluid removed leaving the area clear and EMD will be applied from the farthest end of the involved furcation until the proximal surface of the tooth is covered with EMD and membrane will be adapted to the defect. Patients will be recalled at 1, 3, and 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for voluntary participation & have signed informed consent for the described procedure.
Systemically healthy patients (ASA I & II) with Periodontitis
Class II buccal furcation defects of horizontal component more than 3mm on clinical & radiographic evaluation
The sites should exhibit clinical evidence of PPD of more than 3mm and CAL of more than 2mm
Patients with established willingness and ability to perform adequate oral hygiene |
|
| ExclusionCriteria |
| Details |
1.Subjects who have received periodontal flap/regenerative therapy within the past 1 year
Patients who have received antibiotic therapy within the past six months
Pregnant and lactating patients
Smokers and tobacco chewers
Patients who demonstrate poor oral hygiene maintenance after Phase I therapy
Tooth with gingival recession exposing furcation, endodontic-pulpal
involvement, or mobility > Grade II
Systemic illness known to affect the outcomes of periodontal therapy; such as
uncontrolled diabetes mellitus, cardiac diseases, immune-compromised (e.g.,
HIV individuals, under radiotherapy), patients taking medications such as corticosteroids or calcium channel blockers, which are known to interfere with
periodontal wound healing
Patients with any known allergy to drugs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The possible outcome of this study will be to see the improvement in Clinical Attachment Level and Bone forming capacity using Enamel Matrix Derivative in furcation defects |
Baseline
3 Months
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess gingival inflammation |
Baseline
3 Months
6 Months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/09/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontal disease is considered the 6th most prevalent disease in the world.
Periodontitis is an inflammatory disease of the periodontium which elicits an immune
response resulting in the loss of supporting structures of the teeth. The term “furcation
involvement†is used to describe the resorption of the alveolar bone into the bi- and
trifurcation area of multirooted tooth due to progression of periodontal disease, as described
by American Academy of Periodontology. Enamel Matrix Derivative (EMD) is derived from
developing porcine teeth that initiates formation of acellular root cementum and stimulates
development of periodontal ligament and alveolar bone. DFDBA’s osteoinductive property
stimulates bone formation and is related to amount of bone morphogenetic protein that
remains after the demineralization process is completed. GTR helps in guiding the
proliferation of periodontal tissues that aids in healing after periodontal surgery. This study is
done to evaluate the efficacy of EMD and DFDBA graft on bone regeneration in furcation
Class II defects.
In this study 33 patients diagnosed with periodontitis showing pocket depth >5mm
and radiographic evidence of Class II furcation defects will be selected from department of
Periodontology, SPPGIDMS, Lucknow. The patients will be randomly divided into three
groups. Group A (OFD +EMD+GTR), Group B (OFD+DFDBA+GTR) and Group C (OFD
+GTR). Clinical periodontal parameters probing depth [vertical probing depth (VPD)
horizontal probing depth (HPD)], bleeding on probing (BOP), gingival margin position
(GMP), relative vertical and horizontal clinical attachment level (RVCAL and RHCAL), and
radiographic parameters [vertical and horizontal bone level (VBL and HBL) and hard tissue
fill (HTF)] will be taken to check bone height at baseline, 3 months and 6 months after
treatment.
This study will help us know the efficacy of EMD , DFDBA and OFD alone with
GTR in regenerative treatment for furcation defects. We anticipate that this will enable new
or improved treatment of periodontal furcation defects. |