| CTRI Number |
CTRI/2025/05/086283 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Treatment Of Receding Gums Using Soft Tissue Matrix With or Without EMD. |
|
Scientific Title of Study
|
Comparative Evaluation And Assessment Of Root Coverage Using Bovine Derived Collagen Matrix With Or Without Enamel Matrix Derivative: A Clinical Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Kaushik |
| Designation |
Junior Resident |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room No.2,Department of Periodontology,Subharti Dental College And Hospital, Swami Vivekananda Subharti University,NH58,Delhi Haridwar Bypass Road ,Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9068044434 |
| Fax |
|
| Email |
umeetsoumya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivi Khattri |
| Designation |
Associate Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room No.2,Department of Periodontology,Subharti Dental College and Hospital, Swami Vivekananda Subharti University,NH58,Delhi Haridwar Bypass Road ,Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9627600088 |
| Fax |
|
| Email |
shivikhattri123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivi Khattri |
| Designation |
Associate Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room No.2,Department of Periodontology,Subharti Dental College and Hospital, Swami Vivekananda Subharti University,NH58,Delhi Haridwar Bypass Road ,Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9627600088 |
| Fax |
|
| Email |
shivikhattri123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Soumya Kaushik |
| Address |
Room No.2,Department of Periodontology,Subharti Dental College and Hospital, Swami Vivekananda Subharti University,NH58,Delhi Haridwar Bypass Road ,Meerut,250005 |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Soumya Kaushik |
Subharti Dental College And Hospital |
Room No 2 Department of Periodontology Subharti Dental College and Hospital Swami Vivekananda Subharti University NH58 Delhi Haridwar Bypass Road Meerut
Meerut
UTTAR PRADESH |
09068044434
umeetsoumya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Coronally advanced
flap with FIX SofTi®
Collagen Matrix And Emdogain® |
10 patients with Millers class I and class II defects
treated with coronally advanced flap with collagen
matrix and Emdogain®. Follow up for 1 And 3 months will be done |
| Comparator Agent |
Group B Coronally advanced flap with FIX SofTi® Collagen Matrix |
10 patients with Millers class I and class II defects treated with coronally advanced flap with collagen matrix. Follow up for 1 And 3 months will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Presence of Millers Class 1 and Class 2 gingival recession defects in maxillary and mandibular arch
2 Subjects who are systemically healthy with no contraindication to periodontal surgery
3 No previous history of periodontal therapy at the affected teeth
4 Evidence of patients ability to perform good plaque control
|
|
| ExclusionCriteria |
| Details |
1 Subjects having any deleterious habits such as smoking or tobacco chewing
2 Subjects with history of any systemic disease
3 Recession defects associated with demineralization caries radiographic evidence of bone loss deep abrasion or restorations as well as teeth with evidence of pulpal pathology
4 Subjects showing unacceptable oral hygiene compliance during after Phase I therapy
5 Pregnant or lactating females
6 Subjects having undergone any periodontal therapy in the past three months
7 Subjects prescribed with steroidal chemotherapy radiotherapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recession Length And Width Measured In mm Measured By UNC-15 Periodontal Probe And
Vernier Caliper |
At 1 Month and 3
Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical attachment level (in mm) measured by UNC-15 periodontal probe
|
Baseline, 1 month, 3
months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/05/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
INTRODUCTION - Gingival recession is the apical migration of gingival edge to the junction of cementum and enamel (CEJ).Periodontal disease, plaque accumulations, inflammation, poor flossing, vigorous tooth brushing, are all potential causes of gingival recession. Due to the exposed dentin, gingival recession may produce increased sensitivity. AIM- The aim of the study will be to evaluate the efficacy of collagen matrix with or without enamel matrix derivative in recession coverage. OBJECTIVES- Evaluation and comparison of the percentage gain in root coverage, increase in the length and width of recession, increase in width of keratinised gingiva with Collagen matrix and Enamel matrix derivative, and with Collagen matrix alone at baseline,1 month and 3 months post operatively. METHODOLOGY- A total of 20 systemically healthy subjects with Miller’s Class I and Class II recession defect, aged between 18-55 years, will be selected for the study. Patients selected would be randomly divided into two groups: Test Group: 10 recession defects would be covered with resorbable collagen matrix (Fix SofTi®) and enamel matrix derivative (Emdogain®). Control Group: 10 recession defects would be covered with resorbable collagen matrix (Fix SofTi®) alone. RESULT- Follow up at baseline, 1 and 3 months for assessment of clinical attachment level , increase in width of keratinized gingiva and gain in root coverage. Data collected will be statistically analysed. |