| CTRI Number |
CTRI/2024/11/076631 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of gum loss using animal tissue combining with blood protein or tissue taken from roof of mouth |
|
Scientific Title of Study
|
Comparative evaluation of the clinical outcomes of xenogeneic pericardial collagen membrane enriched with Advanced platelet rich fibrin plus And De-Epithelialized Gingival Graft Along with Coronally Advanced Flap in the treatment of gingival recession- A prospective study |
| 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 |
Second year post graduate student |
| Affiliation |
SRM dental college |
| Address |
3rd floor, Department of Periodontology, SRM dental college, Bharathi salai, Ramapuram, Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
9490868365 |
| Fax |
|
| Email |
shailuadari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM dental college |
| Address |
3rd floor, Department of Periodontology, SRM dental college, Bharathi salai, Ramapuram, Chennai.
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Polimera Sanathana |
| Designation |
Second year post graduate student |
| Affiliation |
SRM dental college |
| Address |
3rd floor, Department of Periodontology, SRM dental college, Bharathi salai, Ramapuram, Chennai.
TAMIL NADU
600089
India |
| Phone |
9490868365 |
| Fax |
|
| Email |
shailuadari@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM dental college
3rd floor, Department of Periodontology, SRM dental college, Bharathi salai, Ramapuram, Chennai. |
|
|
Primary Sponsor
|
| Name |
Polimera Sanathana |
| Address |
3rd floor, Department of Periodontology, SRM dental college, Bharathi salai, Ramapuram, Chennai. |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM dental college |
3rd floor, Department of Periodontology, SRM dental college, Bharathi salai, Ramapuram, Chennai. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anupama Tadepalli |
SRM Dental college |
3rd floor, Department of Periodontology, SRM dental college, Bharathi salai, Ramapuram, Chennai.
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
|
| Type |
Name |
Details |
| Intervention |
Group 1(CAF+A-PRF plus and XCM) |
Gingival recession sites treated with xenogeneic pericardial collagen membrane in combination with Advanced platelet rich fibrin membrane plus (CAF+A-PRF plus and XCM) |
| Comparator Agent |
Group 2 (CAF+DFGG) |
Gingival recession sites treated with Coronally advanced flap and De-epithelized free gingival graft for the treatment of recession defects (CAF+DFGG) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy subjects with an age range of 25-50 years.
2. Individuals diagnosed with recession defects in maxillary anteriors and premolars (Cairo’s RT1, RT2 classes of recession).
3. Sites with minimum depth of recession more than or equal to 2mm.
4. Isolated or multiple adjoining recession involving less than or equal to 3 teeth
|
|
| ExclusionCriteria |
| Details |
1. Sites with probing pocket depth more than or equal to 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 Ι therapy.
5. Smokers.
6. Pregnant and lactating women.
7.Patient known allergic response with Equine 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
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within CAF+A-PRF plus and XCM group.
2. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within CAF+DFGG group.
3. To assess and compare the changes in the recession height from baseline to 6 months between CAF+A-PRF plus and XCM and CAF+DFGG groups
|
Baseline to 6months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the percentage of complete root coverage (CRC%) achieved at 6 months between the treatment groups.
2.To assess and compare the patient perception regarding pain following the treatment modalities by using visual analogue scale score (VAS-P) |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| Date of Study Completion (India) |
15/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
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 a prevalent periodontal condition where the apical migration of gingival tissue causes exposure of the root surface and results in hypersensitivity, root caries , esthetic concerns to patients. The coronally advanced flap (CAF) along with connective tissue graft (CTG) is one of the most effective techniques for the management of Miller Class I and II recessions because it offers excellent esthetic results, highest root coverage. However, in patients with multiple gingival recession defects and having thin gingival phenotype, harvesting CTGs of adequate dimensions are clinically challenging due to the limited donor area. Recently the allogeneic or xenogeneic membranes or matrices have been employed along with platelet concentrates to improve root coverage and as an alternative treatment protocol to CTG . In this study we are proposing to compare the efficacy of combination of xenogeneic pericardial membrane and Advanced platelet rich fibrin plus with de-epithelized free gingival graft tissue along with coronally advanced flap in management of maxillary gingival recession. |