| CTRI Number |
CTRI/2024/07/071619 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Comparison of Two Treatments for Receding Gums: Using Titanium Platelet Rich Fibrin (T-PRF) vs. Connective Tissue Graft (CTG) with a Special Tunnel Technique |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of titanium platelet rich fibrin (T-PRF) and connective tissue graft (CTG) harvested from tuberosity area using modified vestibular incision supra periosteal tunnel access (M-VISTA) for management of human gingival recession defects – 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 Sanehi Devidas Punse |
| Designation |
PG student |
| Affiliation |
Datta Meghe Institute of Medical Science |
| Address |
Radhikabai hostel, Datta Meghe Institute of Medical Science, (Sawangi) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284717880 |
| Fax |
- |
| Email |
punsesanehi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P.V.Dhadse |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science |
| Address |
Department of Periodontics, Sharad Pawar Dental College and Hospital, (Sawangi) Datta Meghe Institute of Medical Science, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822689401 |
| Fax |
- |
| Email |
drprasaddhadse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanehi Devidas Punse |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Medical Science |
| Address |
Department of Periodontics, Sharad Pawar Dental College and Hopsital (Sawangi) Datta Meghe Institute of Medical Science, Wardha
Wardha
MAHARASHTRA
445001
India |
| Phone |
9284717880 |
| Fax |
- |
| Email |
punsesanehi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental College and Hospital (Sawangi), Datta Meghe Institute of Medical Science and Research, Sawangi, Wardha, India Pin code: 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute oh Higher Education and Research Sawangi Wardha |
| Address |
Department of Periodontics, Sharad Pawar Dental College, Datta Meghe Institute oh Higher Education and Research Sawangi, Wardha, India Pin code 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanehi Devidas Punse |
Sharad Pawar Dental College, (Sawangi) Wardha |
Department of Periodontics, room no:003, Datta meghe institute of higher education and research, Wardha, 442001
Wardha
MAHARASHTRA |
9284717880
-
punsesanehi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
connective tissue graft (CTG) harvested from tuberosity |
Connective tissue graft (CTG) harvested from the tuberosity is a highly effective technique used in periodontics for addressing various soft tissue deficiencies. The tuberosity, located at the posterior part of the maxilla, provides a rich source of dense, fibrous connective tissue ideal for grafting. This tissue is particularly beneficial for procedures aimed at increasing the thickness and width of keratinized gingiva, covering exposed roots, and treating gingival recession. Harvesting CTG from the tuberosity can offer advantages such as greater tissue availability and potentially less discomfort for the patient compared to other donor sites, like the palate. The dense nature of the tuberosity-derived grafts also enhances stability and integration at the recipient site, leading to more predictable and aesthetically pleasing outcomes in periodontal surgeries. |
| Intervention |
Titanium platelet rich fibrin (T-PRF) |
Titanium Platelet-Rich Fibrin (T-PRF) is an advanced regenerative material increasingly used in periodontics for enhancing wound healing and tissue regeneration. T-PRF is derived from the patients blood and is processed to form a fibrin matrix that contains a high concentration of platelets and growth factors. Unlike traditional PRF, T-PRF utilizes titanium tubes during its preparation, which is believed to enhance the biological properties and longevity of the fibrin matrix. In periodontics, T-PRF is employed in various procedures, including periodontal regeneration, soft tissue grafting, and the treatment of intrabony defects. Its use promotes accelerated healing, improved tissue integration, and reduced post-operative discomfort, making it a valuable tool for improving clinical outcomes in periodontal therapy. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients.
2. Non-smoker, greater than 18 years old at the time of surgery.
3. Teeth presenting Miller class I or II areas having multiple GR on the buccal or labial surfaces, present in either the maxilla or mandible.
4. GR depth of ≥ 2 mm.
5. X-ray of adequate interdental bone (separation across crestal bone and CEJ ≤ 2 mm).
|
|
| ExclusionCriteria |
| Details |
1. Smokers and patients using tobacco products.
2. Uncooperative subjects.
3. Inadequate oral hygiene and a plaque score ≥1 after nonsurgical treatment.
4. Record of periodontal surgical treatment in the division chosen for the research.
5. Pregnant woman or lactating mother.
6. Mobile teeth and severely decayed teeth.
7. Irregularly placed teeth.
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome of this study is to assess the effectiveness of connective tissue graft (CTG) harvested from tuberosity area and Titanium platelet rich fibrin (T-PRF) using M-VISTA technique in multiple gingival recession defects.
|
baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The surgical procedure for the control group would be same as test group procedure with deviation that T-PRF clot will be placed using M-VISTA technique on the recession defect area.
|
3 months, 6 months & 1 year |
|
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Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
01/09/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
The current study will be performed in order to assess the effectiveness of connective tissue graft (CTG) harvested from tuberosity area and Titanium platelet rich fibrin (T-PRF) using M-VISTA technique in multiple gingival recession defects 24 patients with at least two adjoining gingival recession (GR) defects would be included in the study. It is a double-blind study. Patients selected before surgery will be randomised to any of the CTG harvested from tuberosity area group or T-PRF membrane, each group consists of 12 patients respectively. |