| CTRI Number |
CTRI/2023/12/060865 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of loss of gums using material obtained from animals or material obtained from patients own blood |
|
Scientific Title of Study
|
Evaluation Of Clinical Efficacy Of Xenogenic Collagen Matrix Loaded With Injectable-PRF And PRF Membrane Obtained By Horizontal Spin Protocol Along With Coronally Advanced Flap In The Management Of Gingival Recession Defects – A Prospective Comparative Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Polimera Sanathana |
| Designation |
First year post graduate student |
| Affiliation |
SRM dental college |
| Address |
3rd floor, Post graduate clinic, Department of Periodontology,
SRM dental college, Bharathi salai, Ramapuram, Chennai, Tamil NÄdu
Chennai
TAMIL NADU
600089
India |
| Phone |
9490868365 |
| Fax |
|
| Email |
shailuadari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM dental college |
| Address |
3rdfloor, Post graduate clinic, Department of Periodontology,
SRM dental college, Bharathi salai, Ramapuram, Chennai, Tamil NÄdu.
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM dental college |
| Address |
3rdfloor, Post graduate clinic, Department of Periodontology,
SRM dental college, Bharathi salai, Ramapuram, Chennai, Tamil NÄdu.
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental College and Hospital, Bharathi salai, Ramapuram, Chennai 600089 |
|
|
Primary Sponsor
|
| Name |
Polimera Sanathana |
| Address |
DEPARTMENT OF PERIODONTOLOGY,SRM DENTAL COLLEGE , RAMAPURAM, CHENNAI, TAMILNADU |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| DrAnupama Tadepalli |
SRM Dental college and Hospital |
3rd floor, Post graduate clinics, Department of Periodontology
Chennai
TAMIL NADU |
9677065517
anupamamds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, SRM Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Coronally advanced flap and injectable platelet rich fibrin (i-PRF) incorporated xenogenic collagen matrix |
Gingival recession sites will be treated with Coronally advanced flap and injectable platelet rich fibrin (i-PRF) incorporated xenogenic collagen matrix. The patients will be followed for 6 months and the outcomes of the treated sites will be assessed at the end of 3 and 6 months. |
| Comparator Agent |
Coronally advanced flap and platelet rich fibrin obtained by horizontal spin protocol |
Gingival recession sites will be treated with Coronally advanced flap and platelet rich fibrin obtained by horizontal spin protocol. The patients will be followed for 6 months and the outcomes of the treated sites will be assessed at the end of 3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Cairo’s RT1 & RT2 class of recession defects in maxillary anteriors and premolars.
2.Sites with minimum depth of recession greater then or equal to 2mm.
3.Isolated or multiple adjoining recession involving less than or equal to 3 teeth. |
|
| ExclusionCriteria |
| Details |
1.Sites with probing pocket depth greater than 4mm.
2.Teeth with mobility and/or associated with trauma from occlusion.
3.Sites with dental caries and prosthetic restorations.
4.Patients who exhibit unacceptable oral hygiene compliance during/or after phase one periodontal therapy.
5.Smokers.
6.Pregnant and lactating women.
7.Patient known allergic response with Porcine derived substances.
8.Patients with known platelet disorders or using any medication that are known to interfere with platelet function.
9.Patients with systemic conditions or disease influencing the course of periodontal disease and therapy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess & compare the changes in the recession height from baseline to 6 months, within & between the treatment groups.
2.To assess and compare the percentage of Complete root coverage achieved at 6months between the treatment groups.
|
Baseline and 6months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To assess & compare the changes in the Gingival thickness from baseline to 6 months, within & between the treatment groups. |
Baseline and 6months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
02/01/2024 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Gingival recession is defined as the apical displacement of gingival margin to the cementoenamel junction exposing the root surfaces which may lead to dentinal hypersensitivity, root caries and aesthetic concerns to patients. Connective tissue graft along with coronally advanced flap is considered as the gold standard treatment protocol in the management of gingival recession. However , due to drawbacks of connective tissue grafts like palatal morbidity as a result of secondary surgical site and patient’s fear of pain the proposed study aims to compare the clinical efficacy of volume stable xenogenic collagen matrix incorporated with injectable platelet rich fibrin versus platelet rich fibrin obtained by horizontal spin protocol in the treatment of gingival recession defects. If both the groups shows similar significant results, in future we may recommend the groups protocol as a choice of treatment in the management of gingival recession defects. |