| CTRI Number |
CTRI/2026/03/105249 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two Gum Grafting Procedures in Healthy Patients for treating Receding Gums and improving Patient Satisfaction |
|
Scientific Title of Study
|
Root Coverage with Connective Tissue Graft Associated with Laterally closed Tunnel Flap or Coronally Advanced Flap-A Randomised 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 |
Dr PRASIDDHA.P |
| Designation |
(Post Graduate Student) |
| Affiliation |
Sri Ramachandra Dental College and Hospitasls |
| Address |
Department of Periodontology,
1st Floor, Room No.5,
Sri Ramachandra Dental College and Hospitals,
No.1 Ramachandra Nagar,
Porur,
Chennai. Department of Periodontology,
1st Floor, Room No.5,
Sri Ramachandra Dental College and Hospitals,
No.1 Ramachandra Nagar,
Porur,
Chennai. Chennai TAMIL NADU 600116 India |
| Phone |
9894785722 |
| Fax |
|
| Email |
d0624001@sriher.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. S. Muthukumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Dental College and Hospitasls |
| Address |
Department of Periodontology,
1st Floor, Room No.5,
Sri Ramachandra Dental College and Hospitals,
No.1 Ramachandra Nagar,
Porur,
Chennai. Department of Periodontology,
1st Floor, Room No.5,
Sri Ramachandra Dental College and Hospitals,
No.1 Ramachandra Nagar,
Porur,
Chennai. Chennai TAMIL NADU 600116 India |
| Phone |
9884118681 |
| Fax |
|
| Email |
muthukumars@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr PRASIDDHA.P |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Ramachandra Dental College and Hospitasls |
| Address |
Department of Periodontology,
1st Floor, Room No.5,
Sri Ramachandra Dental College and Hospitals,
No.1 Ramachandra Nagar,
Porur,
Chennai. Department of Periodontology,
1st Floor, Room No.5,
Sri Ramachandra Dental College and Hospitals,
No.1 Ramachandra Nagar,
Porur,
Chennai. Chennai TAMIL NADU 600116 India |
| Phone |
9894785722 |
| Fax |
|
| Email |
d0624001@sriher.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Dental College and Hospitals |
| Address |
Ramachandra Nagar,
Porur,
Chennai,Tamil Nadu 600116. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 PRASIDDHA P |
Sri Ramachandra Dental College and Hospitals |
Department of Periodontology,
1st Floor, Room No.5,
Sri Ramachandra Dental College and Hospitals,
No.1 Ramachandra Nagar,
Porur,
Chennai-600116 Chennai TAMIL NADU |
9894785722
d0624001@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gingival Recession. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coronally advanced flap + SCTG+ Emdogain |
Participants received coronally advanced flap combined with subepithelial connective tissue graft. Following root surface debridement and conditioning with 24% EDTA for 2 minutes, enamel matrix derivative (Emdogain®) was applied to the root surface. A palatal connective tissue graft was harvested and positioned over the defect, stabilized with sutures. The flap was coronally advanced to completely cover the graft and secured with sling sutures to achieve tension-free primary closure. Palatal site was suture using 3-0 Polypropylene suture (Horizontal criss cross mattress suture) Truseal placed on sutures.
Total duration is 1 hour. |
| Intervention |
Root Coverage with Laterally closed tunnel and Coronally advanced technique with SCTG |
Root coverage was performed using a laterally closed tunnel technique combined with coronal advancement in conjunction with subepithelial connective tissue graft and enamel matrix derivative. After tunnel preparation and root conditioning with 24% EDTA, Emdogain was applied to the root surface. A palatal connective tissue graft was harvested and inserted into the tunnel to cover the exposed root. The gingival tissues were approximated laterally and advanced coronally to achieve complete graft coverage, and stabilized with graft with lasso suture and laterally closed with horizontal internal mattress suture and coronally advanced with sling sutures using 5-0 polyglycolic acid sutures. Palatal site was sutured with 3-0 Polypropylene suture. Truseal applied onto sutures. Total Duration of this Procedure is 1hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
•Systemically healthy patients.
•Patients aged between 18 and 45 yrs
•Presence of isolated single tooth Cairo’s Recession Type 1 which means Gingival recession with no loss of interproximal attachment and Cairo’s Recession Type 2 which means interproximal attachment loss is equal to or less than buccal attachment loss.
•Patients with no medication known to interfere with periodontal tissue health or healing such as steroids, calcium channel blockers, antiepileptic agents and immunosuppressants.
•Patients who are Non-smoker which means never smokes or Former smoker who does not smoke now and has not smoked at all for a minimum of the last 12 consecutive months)
|
|
| ExclusionCriteria |
| Details |
•Patients with abusive habits such as smoking and tobacco chewing.
•Patients with systemic diseases such as diabetic mellitus or Hypertension.
•Immunocompromised patients.
•Presence of Lingual recession in the selected teeth.
•Presence of malocclusion or patients with orthodontic therapy in progress.
•Previous history of surgical periodontal therapy.
|
|
|
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 |
| Root coverage esthetic score |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OHIP Questionnaire |
1 week |
| Early wound index |
1 week |
| 3D Volumetric Evaluation of Soft tissue |
1 year |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
20/03/2026 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
This study is a prospective,
randomized clinical trial aims to address this research gap by comparing the
clinical performance on the gold standard coronally advanced flap and laterally
closed tunnel flap associated with connective tissue graft under magnification
loupes for the treatment of isolated gingival recession in improving the
clinical parameters and patient reported outcomes at 1,3,6 and 12 months follow up .
|