| CTRI Number |
CTRI/2025/09/094370 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two gum recession treatments: one using tissue from under the gums and the other from the bone covering, both paired with a technique to reposition gums. It checks which works better for mild to moderate cases. |
|
Scientific Title of Study
|
Comparative evaluation of the effectiveness of periosteal pedicle graft compared to connective tissue graft in combination with coronally advanced flap technique in treatment of millers class I and II gingival recession
A randomized 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 |
Dr.Deepti Reddy |
| Designation |
PG student |
| Affiliation |
M.A. Dental Sciences and Research Centre |
| Address |
M.A.Rangoonwala dental sciences and research centre,Azam campus 2390-B pune 411001
pune
Pune
MAHARASHTRA
411001
India |
| Phone |
08605111759 |
| Fax |
|
| Email |
deeptireddy2509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Deepti Reddy |
| Designation |
PG Student |
| Affiliation |
M.A.Rangoonwala dental sciences and research centre |
| Address |
M.A.Rangoonwala dental sciences and research centre,Azam campus 2390-B pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
08605111759 |
| Fax |
|
| Email |
deeptireddy2509@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Deepti Reddy |
| Designation |
PG Student |
| Affiliation |
M.A.Rangoonwala dental sciences and research centre |
| Address |
M.A.Rangoonwala dental sciences and research centre,Azam campus 2390-B pune 411001
pune 411001
MAHARASHTRA
411001
India |
| Phone |
08605111759 |
| Fax |
|
| Email |
deeptireddy2509@gmail.com |
|
|
Source of Monetary or Material Support
|
| outpatient department from Rangoonwala dental college Pune 411001 Maharashtra India. |
|
|
Primary Sponsor
|
| Name |
Dr Deepti Reddy |
| Address |
M.A.Rangoonwala dental sciences and research centre,Azam campus 2390-B pune 411001
M.A.Rangoonwala dental sciences and research centre,Azam campus 2390-B pune 411001 |
| 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 Deepti reddy |
M.A. Rangoonwala dental sciences and research centre |
Room no 404 Department of Periodontology 2nd floor Azam campus
Pune
MAHARASHTRA |
08605111759
deeptireddy2509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics commitee of M.C.E society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z789||Other specified health status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Control Group n=15): Will be treated with Connective Tissue Graft using Coronally Advanced Flap Technique. |
Langer and Langer2first described the use of connective tissue grafts (CTG) covered by coronally advanced flap for the treatment of gingival recession. The subepithelial connective tissue graft, because of its high predictability in achieving root coverage, has been considered the gold standard of soft tissue grafting procedures. This technique, however, has the disadvantage of requiring an additional surgical site to harvest the CTG, with its associated morbidities and complications.
|
| Comparator Agent |
Group B (Test Group n=15): 15 sites of Miller’s Class I and Class II recession will be treated with Periosteal Pedicle Graft Using Coronally Advanced Flap Technique. |
AjayMahajan3 developed the periosteal pedicle graft (PPG) technique.3This technique involves the use of periosteal tissue as a graft material to cover denuded root surfaces along with a coronally advanced flap. The rationale behind the use of periosteum as a pedicle graft is its high vascularity, osteogenic potential, and an abundance of fibroblasts, osteoblasts and stem cells, all of which promotes regeneration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with localized multiple gingival recession (Miller Class I or II) on two contralateral sites of the maxillary or mandibular arch with a minimum 2-3 mm recession depth.
2. Age range: 18-50 years.
3. Systemically healthy patients with no contraindications for periodontal surgery.
4. Plaque Index Score (Silness J and Loe. H, 1964)less than 1 post-phase I therapy.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy or lactation.
2. Systemic diseases affecting treatment outcome.
3. Patient using tobacco in smoke or smokeless form.
4. Alcoholics and patients with history of drug abuse.
5. Use of antibiotics or long-term anti-inflammatory medication within the past three months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To clinically evaluate and compare the effectiveness of Periosteal Pedicle Graft compared To Connective Tissue Graft in combination with Coronally Advanced Flap Technique in treatment of Miller’s Class I And II Gingival Recession. |
at baseline at 3 months at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include post-operative pain, morbidity, healing time, keratinized tissue gain, tissue aesthetics, donor site complications (CTG), & surgical ease, with PPG favoring recovery & CTG excelling in tissue stability. |
at baseline , at 3 months, at 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
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
|
This randomized clinical study aims to compare the effectiveness of Periosteal Pedicle Graft (PPG) and Connective Tissue Graft (CTG) in combination with the Coronally Advanced Flap (CAF) technique for treating Miller’s Class I and II gingival recession. Thirty systemically healthy patients, aged 18-50, will be recruited and randomly assigned to two groups: Group A (CTG + CAF) and Group B (PPG + CAF), with 15 participants in each. Preoperative care includes scaling and root planing, followed by reevaluation after 4-6 weeks. Clinical parameters such as plaque index, gingival index, probing depth, and recession depth will be recorded at baseline, 3 months, and 6 months postoperatively. The study will assess root coverage, keratinized tissue width, recession coverage, and esthetic outcomes. Data will be analyzed using SPSS software, and the study will follow ethical guidelines with informed consent from all participants. The objective is to determine if there are significant differences in clinical outcomes between the two grafting techniques in terms of root coverage and periodontal health. |