CTRI Number |
CTRI/2022/09/045303 [Registered on: 07/09/2022] Trial Registered Prospectively |
Last Modified On: |
07/05/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia Dentistry |
Study Design |
Other |
Public Title of Study
|
To Evaluate Coronally Advanced Flap with Chorionic Membrane in Treatment of Isolated Gingival Recession: A Randomized Controlled Trail. |
Scientific Title of Study
|
Comparative Evaluation of Coronally Advanced Flap with and without Chorionic Membrane in the Treatment of Isolated Gingival Recession: A Randomized Controlled Trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Geddam Navya |
Designation |
Post Graduate |
Affiliation |
Sri Venkateshwaraa Dental College |
Address |
Sixth Floor
Room Number 602
Department of Periodontology
13 A Sri Venkateshwaraa Dental College
Pondicherry Villupuram main road
Ariyur Pondicherry
Pondicherry PONDICHERRY 605102 India |
Phone |
9390964123 |
Fax |
|
Email |
Geddamnavya1@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Senthilnathan |
Designation |
Professor and Head of the Department |
Affiliation |
Sri Venkateshwaraa Dental College |
Address |
Sixth Floor
Room Number 602
Department of Periodontology
13 A Sri Venkateshwaraa Dental College
Pondicherry Villupuram main road
Ariyur Pondicherry
Pondicherry PONDICHERRY 605102 India |
Phone |
9443133088 |
Fax |
|
Email |
principal@svdcpondy.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Geddam Navya |
Designation |
Post Graduate |
Affiliation |
Sri Venkateshwaraa Dental College |
Address |
Sixth Floor
Room Number 602
Department of Periodontology
13 A Sri Venkateshwaraa Dental College
Pondicherry Villupuram main road
Ariyur Pondicherry
Pondicherry PONDICHERRY 605102 India |
Phone |
9390964123 |
Fax |
|
Email |
Geddamnavya1@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Dr Geddam Navya |
Address |
Sixth Floor
Room Number 602
Department of Periodontology
13 A Sri Venkateshwaraa Dental College
Pondicherry Villupuram main road
Ariyur Pondicherry |
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 |
Dr Geddam Navya |
Sri Venkateshwaraa Dental College |
Sixth Floor
Room Number 602
Department of Periodontology
13 A Sri Venkateshwaraa Dental College
Pondicherry Villupuram main road
Ariyur Pondicherry Pondicherry PONDICHERRY |
9390964123
geddamnavya1@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee (Human studies) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Coronally Advanced Flap |
Coronally Advanced Flap with Chorionic membrane- Test group Coronally Advanced Flap- Control group |
Intervention |
Coronally Advanced Flap, Chorionic membrane |
Coronally Advanced Flap with Chorionic membrane and Coronally Advanced Flap alone |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
Subjects who are diagnosed with Millers Class- I and Class-II gingival recession in anterior teeth and premolars,
Subjects aged between 18-45 years of both sexes,
Subjects who are willing to participate in the study.
|
|
ExclusionCriteria |
Details |
Participants who had undergone any mucogingival procedures at the selected sites within the previous 3 months,
Subjects with any known disease or intake of any medication that affects periodontal status,
Molar teeth and teeth with poor periodontal prognosis,
Subjects allergic to local anesthesia and chlorhexidine (CHX), antibiotic, and analgesic which would be prescribed,
Subjects with Aggressive periodontitis,
Current Smokers and Alcoholics,
Pregnant or Lactating females,
Subjects who are not willing to participate in the study.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Recession height,
Recession width,
Clinical attachment loss,
width of keratinized gingiva |
At baseline and 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Gingival tissue thickness, Complete root coverage and Mean root coverage. |
At baseline 1 month and 6 months |
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
12/09/2022 |
Date of Study Completion (India) |
02/08/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Gingival recession is the “apical migration of the gingival margin below the cemento-enamel junction (CEJ).†It is a multifactorial disease commonly caused by the accumulation of plaque biofilm resulting in inflammatory periodontal diseases and due to trauma caused by faulty and aggressive tooth brushing. The coronally advanced flap (CAF) is a commonly used method for root coverage, and it has demonstrated very good results in treating gingival recessions regarding root coverage and esthetic outcomes. They possess antimicrobial and antibacterial properties and have shown to reduce inflammation and provide a protein-rich matrix, thereby facilitating the migration of cells at the defect area. Yadav K et al in 2015, concluded that, Chorionic membrane provides an effective alternative to autograft tissue in the treatment of shallow-to-moderate Miller’s Class I and II recession defects. In addition, the self adherent nature of the amniotic membrane significantly reduced surgical time and easier to perform. Chorion membrane has shown to reduce scar formation and inflammation, enhancing healing of the wound. Its matrix contains growth factors such as keratinocyte growth factor, basic fibroblast growth factor, and transforming growth factor-b, which help in regenerating the periodontium and gives a setting for faster healing. |