| CTRI Number |
CTRI/2025/07/090574 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Collagen and Natural Membrane to Treat Receding Gums Using a Gentle, Stitch-Free Technique
|
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of collagen and amniotic in a non invasive approach to root coverage using pinhole surgical technique - a randomised controlled 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 |
Tanvika Mall |
| Designation |
JUNIOR RESIDENT 1 |
| Affiliation |
Santosh Demeed to be University |
| Address |
Department of Periodontics and Oral Implantology , Santosh Dental College , Santosh Deemed to be University
1, Santosh Nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh 201009
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
6388980151 |
| Fax |
|
| Email |
tanvika1897@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivaani Sharrma |
| Designation |
PROFESSOR & HEAD |
| Affiliation |
Santosh Demeed to be University |
| Address |
Department of Periodontics and Oral Implantology , Santosh Dental College , Santosh Deemed to be University
1, Santosh Nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh 201009
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
9971794472 |
| Fax |
|
| Email |
drshivani.sharma@santosh.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Tanvika Mall |
| Designation |
JUNIOR RESIDENT 1 |
| Affiliation |
Santosh Demeed to be University |
| Address |
Department of Periodontics and Oral Implantology , Santosh Dental College , Santosh Deemed to be University
1, Santosh Nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh 201009
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
6388980151 |
| Fax |
|
| Email |
tanvika1897@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Oral Implantology , Santosh Dental College , Santosh Deemed to be University
1, Santosh Nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh 201009 |
| self |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tanvika Mall |
SANTOSH DENTAL COLLEGE |
Department of Periodontics and Oral Implantology , Santosh Dental College , Santosh Deemed to be University
1, Santosh Nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh 201009
Ghaziabad
UTTAR PRADESH |
06388980151
tanvika1897@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE , Santosh Deemed to be University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic membrane |
amniotic membrane is a periodontal tissue regenerative material with scaffold properties . it has anti-inflammatory and antimicrobial properties required for tissue regeneration . |
| Comparator Agent |
Collagen membrane |
Collagen membrane is the standard periodontal tissue regenerative material and but not a very cost effective material |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient in the age group of 18 to 60 years.
Miller Class I or II gingival recessions affecting the canines, vital anterior teeth, or premolars.
The cementoenamel junction (CEJ) must be clearly identifiable, and the gingival thickness in the area of the recession must be at least 1 mm.
The individual must exhibit good periodontal health, with no evidence of active periodontal disease or inflammation.
Participants also agreed to participate and signed an informed consent form.
|
|
| ExclusionCriteria |
| Details |
Patients who failed to maintain proper oral hygiene plaque index is greater than 1 after phase 1 therapy.
Pregnant or lactating females.
Individuals with fully restored teeth, dental mobility, cervical abrasion, caries, or abfraction.
Those with a history of prolonged antibiotic use.
Smokers and individuals who engage in Tobacco chewing.
|
|
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Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Both materials are expected to aid wound healing. The amniotic membrane may improve comfort (VAS) and regeneration (CAL). Key clinical measures include: Recession Depth (RD), Recession Width (RW), Keratinized Tissue Width (KTW), Gingival Thickness (GT), Root Coverage (RC) %, Gingival Index (GI), Plaque Index (PI), and Probing Pocket Depth (PPD). If effective, it could be a cost-efficient option for gingival recession treatment.
|
follow up at baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Gingival Index (GI), Plaque Index (PI), and Probing Pocket Depth (PPD) to assess gingival health, oral hygiene status, and periodontal stability throughout the study period.
|
follow up at baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2025 |
| 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="3"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tanvika1897@gmail.com].
- For how long will this data be available start date provided 30-06-2025 and end date provided 06-06-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Gingival recession refers to the downward movement of the gum line below the cementoenamel junction, leading to root exposure and loss of attachment. It results from a combination of susceptibility factors (e.g., thin gingival biotype, lack of keratinized tissue) and modifiable conditions (e.g., plaque buildup, traumatic brushing, smoking, and systemic diseases like diabetes).
Understanding the etiology is key for prevention and management, with major causes being plaque-induced inflammation and mechanical trauma from improper brushing. Conventional surgical treatments (e.g., free gingival grafts, coronally advanced flaps) are effective but often invasive and esthetically limiting.
To overcome these challenges, minimally invasive techniques like the Pinhole Surgical Technique (PST) were developed. PST involves small pinholes instead of large incisions, minimizing trauma, eliminating sutures, and improving esthetic outcomes.
Additionally, biomaterials such as collagen membranes and amniotic membranes (AM) are used to enhance healing. AM, derived from human placental tissue, promotes soft tissue healing, supports cell migration, and reduces surgical time due to its self-adhesive nature.
The study proposes to evaluate the effectiveness and predictability of PST in combination with AM for treating marginal tissue recession, aiming to improve clinical outcomes with less invasiveness. |