| CTRI Number |
CTRI/2025/04/085830 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
treatment of bone loss with receding gums using soft tissue graft compared with autologous heat compressed platelet-rich- fibrin membrane |
|
Scientific Title of Study
|
Evaluation of the efficacy of Guided tissue regeneration using autologous heat compressed platelet-rich-fibrin membrane compared to subepithelial connective tissue graft in the management of RT1 marginal tissue recession : A Randomized controlled 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 Smitha K |
| Designation |
Professor and Head Of The Department of Periodontology |
| Affiliation |
Government dental college and research institute |
| Address |
room no 3 department of periodontology , government dental college and institute , fort victoria hospital campus , kr market bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9449630572 |
| Fax |
|
| Email |
periosmitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha K |
| Designation |
Professor and Head Of The Department of Periodontology |
| Affiliation |
Government dental college and research institute |
| Address |
room no 3 department of periodontology , government dental college and institute , fort victoria hospital campus , kr market bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9449630572 |
| Fax |
|
| Email |
periosmitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surabhi |
| Designation |
postgraduate student |
| Affiliation |
Government Dental College and Research Institute |
| Address |
room no 3 department of periodontology , government dental college and institute , fort victoria hospital campus , kr market bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
8447967848 |
| Fax |
|
| Email |
surabhisunil1604@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and research institute, near city market, kalasipalya, bengaluru, karnataka, 560002 |
|
|
Primary Sponsor
|
| Name |
Government Dental College And Research institute Bangalore |
| Address |
victoria hospital, near city market, kalasipalya, bengaluru, karnataka, 560002 |
| 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 Surabhi |
Government Dental College and Research Institute, Bangalore |
room no-03, department of periodontology,victoria campus city market, kalasipalya, bengaluru, karnataka 560002
Bangalore
KARNATAKA |
7073810479
surabhisunil1604@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee and Review Board , Government Dental College and Research Insititute, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coronally advanced flap with
autologous heat compressed-
platelet rich fibrin membrane |
The Zucchelli and De Sanctis 2007 coronally advanced flap procedure is used to treat isolated gingival recession. Heat compressed PRF membrane
is prepared with the protocol given by Kawase, et al
To obtain the Heat compressed-PRF membrane, blood collection is performed using 10ml vacutainer
tubes without any additive by venipuncture of antecubital vein at the time of surgery. After collection, it
is centrifuged at 2700 rpm for 12 minutes. Half PRF part is taken, placed and compressed between sterile
glass slides and slides are heated by dry heat at 65 degree celcius for 2 to 15 sec. Heat compressed PRF membrane
is formed and bring to a thickness of approximately 0.2 mm. This heat compressed membrane will be
coated with remaining PRF membrane and placed covering the defect |
| Intervention |
Coronally Advanced Flap with
Subepithelial Connective Tissue
Graft |
The Zucchelli and De Sanctis 2007 coronally advanced flap procedure is used to treat isolated gingival recession. Recession depth is first measured to plan incisions. After giving local anesthesia, an intrasulcular incision is made with a 12 or 15c blade. Two small horizontal incisions are placed slightly above the papilla tip, based on the recession depth plus one millimeter. Two vertical beveled incisions are made into the mucosa without touching the bone or periosteum to prevent scarring. A split full split flap is then raised. The flap is placed one to two millimeters above the CEJ and sutured in place.
A connective tissue graft is taken from the palate using the trap door method, avoiding important nerves and blood vessels. A horizontal cut is made two millimeters from the gum line, along with two vertical cuts to access the graft. The flap is raised in a split thickness way, and the graft is trimmed after removing unwanted tissue. The donor site is closed with sling sutures using nonresorbable silk. The graft is placed one millimeter below the CEJ, covering the defect and the space between teeth, and secured with absorbable sutures. Finally, the buccal flap is advanced to cover the graft and sutured in place over the interdental area.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.localised gingival recession of at least 2mm in depth with minimum width of attached gingiva as more than 3mm apical to recession
2.presence of identifiable buccal cemento-enamel-junction without any carious, non carious, cervical lesion or restoration
3.in good general health(ASA 1)
4.palatal mucosal thickness more than 2.5 mm as assesses by trans gingival probing which serves as donor site |
|
| ExclusionCriteria |
| Details |
1.pregnancy and lactating women
2.teeth with evidence of a pulpal pathology and a non-vital tooth
3.teeth that had periodontal surgical procedure for root coverage in the last 2 years
4.subjects who are active smokers at the time of screening
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Recession depth reduction [Time Frame:6 months]
-Measured from the reference stent margin to the most apical extension of the gingival margin; will be measured in mm
2.Mean root coverage (MRC), calculated as
[(Baseline RD) – (6 months RD)/Baseline RD] × 100%.
3.complete root coverage (CRC), calculated as the percentage treated site with 100% coverage
|
0-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain assessment at the donor site [ Time Frame: 7 days]
-Visual Analogue Scale
2.Number of analgesic pills consumed per day [ Time Frame:1- 7 days]
-counting number of analgesic pills per day
3.Height of keratinized tissue width [ Time Frame: baseline and at 6 months]
-measured form the mid-buccal aspect of the gingival margin to the mucogingival line
4.Relative attachment level [ Time Frame: baseline-3-6 months]
-Measured from the stent margin to the bottom of the periodontal pocket to the nearest mm.
5.Root Coverage Esthetic score. [Baseline- 6 months] |
0-6 months |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/06/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 randomized controlled clinical study aims to evaluate and compare the effectiveness of two guided tissue regeneration techniques in treating localized marginal gingival recession . A total of 32 subjects will be enrolled and randomly assigned into two equal groups Active Comparator Group will be Treated with a coronally advanced flap in combination with autologous heat-compressed platelet-rich fibrin membrane Control Group will be Treated with a coronally advanced flap along with a subepithelial connective tissue graft , which is the gold standard. The goal is to assess clinical outcomes such as root coverage, tissue thickness, and esthetic integration, determining whether heat compressed platelet-rich fibrin membrane can serve as a viable alternative to subepithelial connective tissue graft in the management of localized marginal tissue recession defects. Additionally , biomarkers like Angiogenin and Human Cementum Protein will evaluate vascularization and healing. |