| CTRI Number |
CTRI/2024/07/071007 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Tunneled coronally advanced flap in the treatment of receding gums |
|
Scientific Title of Study
|
Tunneled coronally advanced flap versus Modified coronally advanced flap in combination with amnion membrane for the treatment of multiple gingival recession – A Randomized 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 |
Pragya Atray |
| Designation |
Postgradute |
| Affiliation |
Manipal College of Dental Sciences, Mangalore, Karnataka |
| Address |
Department of Periodontology, 4th floor, Manipal
College of Dental Sciences, Mangalore.
Affiliated to Manipal Academy of Higher Education, Manipal
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
09759803280 |
| Fax |
|
| Email |
atray.pragya28@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sangeeta U Nayak |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Mangalore, Karnataka |
| Address |
Department of Periodontology, 4th floor, Manipal
College of Dental Sciences, Mangalore.
Affiliated to Manipal Academy of Higher Education, Manipal
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9880718372 |
| Fax |
|
| Email |
sangeeta.nayak@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Sangeeta U Nayak |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Mangalore, Karnataka |
| Address |
Department of Periodontology, 4th floor, Manipal
College of Dental Sciences, Mangalore.
Affiliated to Manipal Academy of Higher Education, Manipal
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9880718372 |
| Fax |
|
| Email |
sangeeta.nayak@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College Of Dental Sciences, Mangalore, karnataka
pin- 575001, India |
|
|
Primary Sponsor
|
| Name |
Pragya Atray |
| Address |
Department of Periodontology, 4th floor, Manipal
College of Dental Sciences, Mangalore.
Affiliated to Manipal Academy of Higher Education, Manipal
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| Pragya Atray |
Manipal College Of Dental Sciences, Mangalore |
Department of Periodontology, 4th floor, Manipal
College of Dental Sciences, Mangalore.
Affiliated to Manipal Academy of Higher Education, Manipal
Dakshina Kannada KARNATAKA |
9759803280
atray.pragya28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manipal College of Dental Sciences, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
systemically healthy patients
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified coronally advanced flap in combination with amnion membrane |
Tunneled coronally advanced flap versus modified coronally advanced flap in combination with amnion membrane for the treatment of multiple gingival recession |
| Intervention |
Tunneled coronally advanced flap in combination with amnion membrane |
Tunneled coronally advanced flap versus modified coronally advanced flap in combination with amnion membrane for the treatment of multiple gingival recession |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with esthetic concern or hypersensitivity associated with GR,
2. Age ≥ 18 years, Systemically healthy and willing to sign consent form and agreeing to participate in the study
3. Presence of RT1 or RT2 multiple adjacent GRs,
4. At least 1.5 mm of keratinized tissue width (KTW) around the included teeth.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with an uncontrolled systemic disease (e.g., diabetes, etc.),
2. Smokers,
3. Presence of active periodontal disease,
4. Individuals taking medications, which could interfere with the healing of the soft tissues,
5. Known allergy to any of the biomaterials to be used.
6. Pregnant and lactating
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
recession depth
recession width
probing depth
gingival thickness
clinical attachment level
Keratinized tissue width
Mean Root Coverage
Complete Root Coverage
Root coverage esthetic score |
Baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PROM Patient Reported Outcome Measures |
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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)
|
12/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 can arise from various predisposing and precipitating factors, as noted by Hall in 1984. Effective management of gingival recession involves not only eliminating these factors but also repositioning the gingiva to its original position. Numerous surgical methods have been developed, combining various grafting materials—such as autologous, allogenic, or xenogeneic—and surgical designs like flaps and tunneling procedures. The two most commonly used methods are the coronally advanced flap (CAF) and the tunnel technique (TUN). In 2022, Barootchi et al. introduced an innovative approach that combines CAF and TUN, termed the Tunneled Coronally Advanced Flap (TCAF). This technique, when combined with connective tissue graft (CTG), was suggested to be effective for treating isolated RT2 gingival recessions, potentially enhancing flap blood supply, graft vascularization, and patient-reported outcomes, along with clinical and aesthetic improvements. Despite the advantages of connective tissue transplantation for gingival recession, the scarcity of grafts and the need for a secondary surgical site limit its utility. Consequently, guided tissue regeneration (GTR) using allograft membranes has been employed, showing promising results. Human placental membranes, like amnion and chorion, have been used successfully in medicine for healing burns and ulcerated skin disorders, owing to their unique biological properties that promote wound healing and may encourage regeneration. These membranes also have anti-adhesive effects, are bacteriostatic, provide wound protection, reduce pain, and aid epithelialization, making them suitable for GTR in dental applications. This study aimed to compare the efficacy of modified coronally advanced flaps (MCAF) and tunneled coronally advanced flaps (TCAF), both combined with amnion membrane, in treating gingival recessions. A parallel-mouth randomized controlled trial was conducted with ten patients (five men and five women) aged between 38 and 45, presenting with 34 gingival recession defects. Participants were randomly assigned to either the test group (TCAF) or the control group (MCAF), each consisting of five patients. The test group underwent the tunneled coronally advanced flap procedure with an amnion membrane for treating RT1 and RT2 gingival recessions, while the control group underwent the modified coronally advanced flap technique with an amnion membrane for similar conditions. Inclusion criteria required patients to be 18 years or older, have esthetic concerns or hypersensitivity due to gingival recession, and be systemically healthy. Exclusion criteria included uncontrolled systemic diseases, smoking, active periodontal disease, medications affecting soft tissue healing, allergies to the biomaterials used, and pregnancy or lactation. Patients received nonsurgical therapy, including scaling and root planing, followed by oral hygiene instructions. Clinical parameters such as probing depth (PPD), gingival recession width (GRW), width of keratinized tissue (WKT), and gingival tissue (GT) were measured at baseline and six months by a masked examiner. A "root coverage esthetic score" (RES) was used to evaluate aesthetic outcomes. For the surgical procedures, the control group underwent a split-full-split thickness flap without vertical releasing incisions, and the amnion membrane was placed over the root surfaces before advancing the flap coronally. The test group involved a vertical incision, creation of a split-full-split thickness flap, and tunneling to place the amnion membrane within the flap, secured with sutures. Post-surgical care included prescribing antibiotics and using chlorhexidine mouthwash, with oral hygiene instructions and suture removal after 14 days. Clinical indicators were re-measured at three and six months, and patient satisfaction was assessed using the visual analogue scale (VAS) at baseline and six months. Statistical analysis, conducted using SPSS software, involved paired t-tests for intragroup comparisons and unpaired t-tests for intergroup comparisons. |