UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058041 |
|---|---|
| Receipt number | R000066343 |
| Scientific Title | COMPARATIVE EVALUATION OF CORONALLY ADVANCED FLAP WITH MUCODERM AND CORONALLY ADVANCED FLAP ALONE IN MANAGEMENT OF GINGIVAL RECESSION - A CLINICAL STUDY |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/06/02 01:39:25 |
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Basic information
Public title
COMPARATIVE EVALUATION OF CORONALLY ADVANCED FLAP WITH MUCODERM AND CORONALLY ADVANCED FLAP ALONE IN MANAGEMENT OF GINGIVAL RECESSION - A CLINICAL STUDY
Acronym
COMPARATIVE EVALUATION OF CORONALLY ADVANCED FLAP WITH MUCODERM AND CORONALLY ADVANCED FLAP ALONE IN MANAGEMENT OF GINGIVAL RECESSION - A CLINICAL STUDY
Scientific Title
COMPARATIVE EVALUATION OF CORONALLY ADVANCED FLAP WITH MUCODERM AND CORONALLY ADVANCED FLAP ALONE IN MANAGEMENT OF GINGIVAL RECESSION - A CLINICAL STUDY
Scientific Title:Acronym
COMPARATIVE EVALUATION OF CORONALLY ADVANCED FLAP WITH MUCODERM AND CORONALLY ADVANCED FLAP ALONE IN MANAGEMENT OF GINGIVAL RECESSION - A CLINICAL STUDY
Region
| Asia(except Japan) |
Condition
Condition
Gingival Recession is a common periodontal condition that leads to aesthetic concerns and potential tooth sensitivity. Various surgical approaches have been developed to manage this condition, with the Coronally Advanced Flap (CAF) being one of the most frequently employed techniques. Recent advances have introduced Mucoderm, a Collagen Matrix, to enhance outcomes when combined with CAF. However, the comparative efficacy of CAF alone versus CAF combined with Mucoderm remains under-explored.
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare the clinical outcomes of Gingival Recession treatment using the Coronally Advanced Flap (CAF) alone versus Coronally Advanced Flap (CAF) combined with Mucoderm in terms of Root Coverage, Thickness, Clinical Attachment Level, Patient Centered Outcome Measures and Professional Esthetic Evaluation.
Basic objectives2
Others
Basic objectives -Others
To comparatively evaluate the Clinical effectiveness of Coronally Advanced Flap with and without Xenogenic Collagen Membrane (Mucoderm) in management of Millers Class I and Class II Gingival Recession.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare and evaluate the changes in Clinical Parameters such as Recession Depth (RD), Gingival Thickness (GT) and Width of Attached Gingiva (WAG) among patients undergoing surgical treatment with Coronally Advanced Flap with Mucoderm (Test group) and Coronally Advanced Flap alone (Control group) at baseline, 1 month and 3 months post-treatment.
Key secondary outcomes
To assess Patient-Reported Outcome Measures (PROMs) using Visual Analogue Scale (VAS) scores at 2 weeks and Questionnaires (patient satisfaction) at 3 months, and Professional Esthetic Evaluation using Root Coverage Esthetic Score (RES) at 3 months, among patients undergoing surgical treatment with Coronally Advanced Flap with Mucoderm (Test group) and Coronally Advanced Flap alone (Control group).
To compare and evaluate the changes in Clinical Parameters especially Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL) among patients undergoing surgical treatment with Coronally Advanced Flap with Mucoderm (Test group) and Coronally Advanced Flap alone (Control group) at baseline, 1 month and 3 months post-treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CORONALLY ADVANCED FLAP AND MUCODERM FOR ROOT COVERAGE
Interventions/Control_2
CORONALLY ADVANCED FLAP ALONE FOR ROOT COVERAGE
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Presence of Gingival Recession of Miller Class I or Class II.
Age of 18 to 40 years old.
Systemically healthy with no contraindications for periodontal surgery.
Absence of clinical signs of active periodontal disease.
Key exclusion criteria
Systemic disease with compromised healing potential or infectious disease.
Usage of medication known to affect gingival conditions (hyperplasia) or to
interfere with healing (steroids).
Pregnant or Lactating mothers.
Non-vital teeth, caries, prosthetic crowns or restorations involving the
cemento-enamel junction area.
Tobacco smoking, drug or alcohol abuse.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | JANE |
| Middle name | CAROLYN |
| Last name | MAANSINGH |
Organization
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Division name
DEPARTMENT OF PERIODONTICS AND IMPLANT DENTISTRY
Zip code
625001
Address
129, EAST VELI STREET, MADURAI, TAMILNADU, INDIA
TEL
+919843110466
janecsiperio@gmail.com
Public contact
Name of contact person
| 1st name | JANE |
| Middle name | CAROLYN |
| Last name | MAANSINGH |
Organization
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Division name
DEPARTMENT OF PERIODONTICS AND IMPLANT DENTISTRY
Zip code
625001
Address
129, EAST VELI STREET, MADURAI, TAMILNADU, INDIA
TEL
+919843110466
Homepage URL
janecsiperio@gmail.com
Sponsor or person
Institute
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Institute
Department
Personal name
DR.V.R.BALAJI
Funding Source
Organization
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH
Address
129, EAST VELI STREET, MADURAI-625001, TAMILNADU, INDIA
Tel
0452 - 2321709
csidentalethicalcommittee@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
NO ADVERSE EVENTS REPORTED
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066343
