| CTRI Number |
CTRI/2023/08/056045 [Registered on: 02/08/2023] 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, Active Controlled Trial |
|
Public Title of Study
|
Management of gum loss using patients own tissue and animal derived material coated with patient blood product |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Efficacy of Volume Stable Xenogenic Collagen Matrix Incorporated With Injectable Platelet Rich Fibrin And De-Epithelialized Gingival Graft Along With Coronally Advanced Flap in The Management of Gingival Recession Defects – A Comparative Clinical 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 |
First year post graduate student |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
DEPARTMENT OF PERIODONTOLOGY,SRM DENTAL COLLEGE , RAMAPURAM, CHENNAI, TAMILNADU
DEPARTMENT OF PERIODONTOLOGY, SRM DENTAL COLLEGE , RAMAPURAM, CHENNAI, TAMILNADU
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 |
DEPARTMENT OF PERIODONTOLOGY, SRM DENTAL COLLEGE , RAMAPURAM, CHENNAI, TAMILNADU
DEPARTMENT OF PERIODONTOLOGY, SRM DENTAL COLLEGE , RAMAPURAM, CHENNAI, TAMILNADU
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 |
DEPARTMENT OF PERIODONTOLOGY, SRM DENTAL COLLEGE , RAMAPURAM, CHENNAI, TAMILNADU
DEPARTMENT OF PERIODONTOLOGY, SRM DENTAL COLLEGE , RAMAPURAM, CHENNAI, TAMILNADU
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Polimera Sanathana |
| Address |
c2-145, KRP Colony, Pulicat nagar, SPSR Nellore District, ANDHRAPRADESH |
| 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 |
| Dr Anupama Tadepalli |
SRM Dental college and Hospital |
3rd floor, Post graduate clinics, Department of Periodontology, 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 |
| INSTITUTIONAL ETHICAL COMMITTEE AND 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 |
| Comparator Agent |
Control group |
Gingival recession sites treated with coronally advanced flap and de-epithelized free gingival graft |
| Intervention |
Test group |
Gingival recession sites treated with coronally advanced flap and volume stable xenogeneic collagen matrix impregnated with injectable platelet rich fibrin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals diagnosed with 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
|
Computer generated randomization |
|
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 & compare the percentage of Complete root coverage achieved at 6months between the treatment groups.
|
Baseline, 3 & 6 months |
|
|
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 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
15/09/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 a apical migration of gingival margin to the cementoenamel junction exposing the root surface which may lead to dentinal hypersensitivity, root caries and aesthetic concerns to patients. Gold standard treatment protocol for management of gingival recession is the autologous graft obtained from palate. However donor site may not be adequate in all the subjects to manage multiple recessions. The proposed study aims to compare the clinical efficacy of volume stable xenogeneic collagen matrix incorporated with injectable platelet rich fibrin versus de-epithelized gingival graft in the treatment of gingival recession defects. If the intervention group shows similar significant results as the control group, in future we may recommend the intervention group protocol as a choice of treatment in the patients who don’t have adequate donor tissue and are fearful about second surgical site for procuring graft. |