| CTRI Number |
CTRI/2024/05/067734 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of gum loss in gum disease individuals using animal derived membrane along with patients blood derived substances |
|
Scientific Title of Study
|
Comparative evaluation of the clinical outcomes of xenogeneic pericardial collagen membrane enriched with two different forms of platelet concentrates 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 |
Kiran choudhary |
| Designation |
First year postgraduate student |
| Affiliation |
SRM dental college |
| Address |
Department of Periodontology, SRM dental college,
Ramapuram, Chennai,
Tamil Nadu , 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9666966033 |
| Fax |
|
| Email |
kc4893@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DRANUPAMA TADEPALLI |
| Designation |
PROFESSOR |
| Affiliation |
SRM dental college |
| Address |
Department of periodontology , SRM dental college,
Ramapuram, Chennai,
Tamil Nadu , 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRANUPAMA TADEPALLI |
| Designation |
PROFESSOR |
| Affiliation |
SRM dental college |
| Address |
Department of periodontology , SRM dental college,
Ramapuram, Chennai,
Tamil Nadu , 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental college , Department of Periodontology , 3rd floor , Bharathi Salai , Ramapuram campus , Chennai , Tamil Nadu , India, 600089 |
|
|
Primary Sponsor
|
| Name |
kiran choudhary |
| Address |
1st yr MDS student, Department of Periodontology, SRM Dental college, Bharathi salai, Ramapuram campus, Chennai 600089 |
| Type of Sponsor |
Other [Self funded ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM Dental College |
Department of Periodontology, SRM Dental college, Bharathi salai, Ramapuram campus, Chennai 600089 |
|
|
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 |
Department of Periodontology, 3rd floor , SRM dental college , Bharathi salai, Ramapuram, Chennai, 600089
Chennai
TAMIL NADU |
9677065517
anupamamds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM DENTAL COLLEGE INSTITUTIONAL REVIEW BOARD |
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 Xenogeneic pericardial membrane impregnated with injectable platelet rich fibrin(XCM+i-PRF) |
The gingival recession sites will be treated with xenogeneic pericardial collagen membrane(XCM) impregnated with injectable platelet rich fibrin(I-PRF) along with coronally advanced flap(CAF) and follow-up will be done for 6 months. |
| Comparator Agent |
Group 2 xenogeneic pericardial collagen membrane in combination with advanced platelet plus(XCM+A-PRF plus) |
The gingival recession sites will be treated with xenogeneic pericardial collagen membrane (XCM) in combination with Advanced platelet rich fibrin plus membrane(A-PRF plus) along with coronally advanced flap(CAF)and follow-up will be done for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy subjects with an age range of 18-65 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 ≥2mm.
4. Isolated or multiple adjoining recession involving ≤3 teeth. |
|
| ExclusionCriteria |
| Details |
1. Sites with probing pocket depth ≥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 |
| To assess and compare the changes in the recession height from baseline to 6 months, within and between the study groups |
Baseline and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare the percentage of complete root coverage (CRC%) achieved at 6 months between the research groups
2.To assess and compare the patient perception regarding esthetics following the treatment modalities by using Visual Analogue Scale scores (VAS-E)
|
6months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| Date of Study Completion (India) |
28/06/2025 |
| 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)
|
Not Applicable |
| 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 common 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 animal derived xenogeneic collagen membrane along with platelet concentrates have gained attention in successful root coverage procedures . In this study we are proposing to compare the efficacies of xenogeneic collagen membrane along with two different types of platelet concentrates, that is, injectable platelet rich fibrin versus advanced platelet rich fibrin plus |