| CTRI Number |
CTRI/2024/06/068420 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The use of tissue from inner and upper aspect of mouth versus animal derived substitute material that is available in the market in the patients having receding gums using a technique involving pulling the gums upward. |
|
Scientific Title of Study
|
Impact of Xenogenic collagen matrix on COL1A1 gene expression in patients with multiple gingival recession defects- A Randomised Controlled 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 |
Arvina Rajasekar |
| Designation |
professor |
| Affiliation |
Saveetha dental college and hospital, SIMATS UNIVERSITY |
| Address |
Department of periodontology, clinic 25, 4th floor, no. 162,Poonamallee high road, Vellapanchavadi, chennai 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9486442309 |
| Fax |
|
| Email |
arvinar.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vazeeha afrin syed |
| Designation |
post graduate |
| Affiliation |
Saveetha dental college and hospital, SIMATS UNIVERSITY |
| Address |
Department of periodontology, clinic 25, 4th floor, no.162, poonamallee high road, vellapanchavadi,
Chennai
TAMIL NADU
600077
India |
| Phone |
09618696972 |
| Fax |
|
| Email |
152205001.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Arvina Rajasekar |
| Designation |
professor |
| Affiliation |
Saveetha dental college and hospital, SIMATS UNIVERSITY |
| Address |
Department of periodontology, clinic 25, 4th floor, no. 162,Poonamallee high road, Vellapanchavadi, chennai 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9486442309 |
| Fax |
|
| Email |
arvinar.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospital, SIMATS UNIVERSITY clinic 25, 4th floor, no. 162,Poonamallee high road, Vellapanchavadi, chennai 600077 |
|
|
Primary Sponsor
|
| Name |
saveetha dental college and hospital |
| Address |
Saveetha dental college and hospital Department of periodontology clinic 25, 4th floor, no. 162,Poonamallee high road, Vellapanchavadi, chennai 600077 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| vazeeha afrin syed |
Department of periodontology clinic 25, 4th floor, no. 162,Poonamallee high road, Vellapanchavadi, chennai 600077 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arvina R |
saveetha dental college and hospital |
Department of periodontology, clinic 25, 4th floor, no. 162,Poonamallee high road, Vellapanchavadi, chennai 600077
Chennai
TAMIL NADU |
9486442309
arvinar.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| saveetha dental college-institutional human ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with RT1 and RT2 gingival recession. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Connective tissue graft (CTG) with coronally advanced flap (CAF). |
Connective tissue graft (CTG) used for recession management using coronally advanced flap technique at the time of surgical intervention after baseline. |
| Intervention |
Fibro-gide material with coronally advanced flap(CAF). |
Commercially available xenogenic material Fibro-gide used for recession management using coronally advanced flap technique at the time of surgical intervention after baseline evaluation and to be reevaluated after 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18 to 60 years.
2. RT 1 and RT 2 gingival recession in upper teeth with a recession depth ≥ 2mm.
3. Probing depth ≤ 4mm. |
|
| ExclusionCriteria |
| Details |
1. Systemic disease
2. presence of caries at recession site.
3. tooth with mobility.
4. Pregnancy
5. use of medications with potentially adverese effects on periodontal tissues
6. smokers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean root coverage (MRC), recession height (RH), recession width (RW), width of keratinized tissue (WKT), probing pocket depth (PPD), clinical attachment level gain (CAL). |
baseline
6months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COL1A1 gene expression |
baseline
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/06/2024 |
| 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="6"
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
|
Gingival recession is defined as the apical shift of the marginal gingiva resulting in dentin hypersensitivity, root caries, an unaesthetic gingival appearance. Management of gingival recession include conventional flap and autogenous grafting procedures. Due to the limited tissue availability and post-operative morbidity, xenogenic collagen matrices are gaining popularity in recent days. In this context, the aim of this study was to assess the effectiveness of xenogenic collagen matrix (Fibro-Gide®) with coronally advanced flap compared to connective tissue graft with coronally advanced flap in the management of RT1 and RT2 gingival recessions.
|