| CTRI Number |
CTRI/2024/07/071304 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the effects of concentrated growth factor versus platelet rich fibrin membrane on root coverage surgery in patients having gum recession |
|
Scientific Title of Study
|
Comparative Evaluation of Coronally Advanced Flap in Conjunction with Concentrated Growth Factor versus Coronally Advanced Flap with Platelet Rich Fibrin Membrane in patients with Cairos RT1 Isolated Gingival Recession Defects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramya V |
| Designation |
Postgraduate |
| Affiliation |
Adhiparasakthi dental college and hospital |
| Address |
Department of periodontics and Implantology
Room No 5
Adhiparasakthi dental college and Hospital
Melmaruvathur
Chengalpattu District
Chennai
TAMIL NADU
603319
India |
| Phone |
8220858508 |
| Fax |
|
| Email |
jesintharamya.99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Magesh kumar S |
| Designation |
Professor and Head |
| Affiliation |
Adhiparasakthi dental college and Hospital |
| Address |
Department of periodontics and Implantology
Room NO 5
Adhiparasakthi dental college and Hospital
Melmaruvathur
Chengalpattu district
TAMIL NADU
603319
India |
| Phone |
7060027522 |
| Fax |
|
| Email |
drmagesh76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramya V |
| Designation |
Postgraduate |
| Affiliation |
Adhiparasakthi dental college and Hospital |
| Address |
Department of Periodontics and Implantology
Room No 5
Adhiparasakthi dental college and Hospital
Melmaruvathur
Chengalpattu District
TAMIL NADU
603319
India |
| Phone |
8220858508 |
| Fax |
|
| Email |
jesintharamya.99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Implantology
Adhiparasakthi dental college and Hospital
Melmaruvathur
Chengalpattu District-603319
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
Ramya V |
| Address |
Department of Periodontics and Implantology
Room No 5
Adhiparasakthi dental college and Hospital
Melmaruvathur
Chengalpattu District-603319
Tamilnadu
|
| 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 |
| Ramya V |
Adhiparasakthi dental college and Hospital |
Department of Periodontics and Implantology
Room No 5
Melmaruvathur
Chengalpattu District-603319
Chennai
TAMIL NADU |
8220858508
jesintharamya.99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Adhiparasakthi Dental College and Hospital Melmaruvathur-603319 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
concentrated growth factor |
CGF has a 3D fibrin network in which growth factors are closely bound to one another. This provides the slow release of growth factors, which helps with wound healing.CGF will be given at baseline and total duration will be 6 months |
| Intervention |
Platelet rich fibrin |
platelet rich fibrin has regenerative property and regeneration capacity of PRF is due to its angiogenesis potential, which can be explained by the 3D fibrin matrix that can carry, at the same time, cytokines and GFs such as VEGF, IGF, TGF-β1 and PDGF.PRF is given at baseline and total duration will be 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals aged between 20 to 60 years
Patients with Cairo’s RT1 isolated gingival recession bilaterally
Patients with gingival recession greater than or equal to 2mm depth and width
Patient should have a minimum of 3 mm of keratinized gingiva present apical to the exposed root with no loss of inter dental bone or soft tissue, and adequate thickness of keratinized gingiva in the surgical site
|
|
| ExclusionCriteria |
| Details |
Systemic illness known to affect the outcome of periodontal therapy
Patients who use tobacco in any form
Pregnant and lactating women
Patients undergoing orthodontic therapy
Patients on antibiotics in last 6months
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete root coverage |
Baseline,3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level, Recession Depth, Recession Width, Keratinized Gingival Width, Gingival Thickness |
Baseline,3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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)
|
01/11/2024 |
| 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="1"
Months="6"
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
|
· Patients recruited for the study will receive detailed explanations regarding the procedure and written informed consent will be obtained from each patient a At the baseline the clinical parameters such as Plaque Index, Gingival Index, Pocket Probing Depth, Clinical Attachment Level, Recession Depth, Recession Width, Keratinized Gingival Width, Gingival Thickness will be measured · All the patients will undergo phase I therapy of treatment consisting of thorough Supragingival Professional Mechanical Plaque Removal (PMPR) and oral hygiene instructions will be given to the patient. Patient will be re-evaluated after 3 weeks of Supragingival Professional Mechanical Plaque Removal(PMPR) to assess the plaque scores. Patient with plaque score less than 20 percentage will be eligible for the study. Within each patient randomly selected sites is divided into group A and group B T The selected sites will be anaesthetized locally by administration of 2% xylocaine HCl anaesthetic solution containing adrenaline (1:80,000) prior to initiating the procedure To To elevate the coronally advanced flap, two oblique vertical incisions of the triangular flap will be made at the level of cementoenamel junction and extending parallel to the soft tissue margin of the adjacent healthy teeth beyond the mucogingival line. T The flap will then be elevated following a split-full-split-thickness approach in the coronal to apical direction and muscle attachment at mucogingival level will be relieved to sufficiently mobilize the flap and to advance it coronally by 1mm to cover the gingival recession. De epithelisation of the interdental papilla will be performed to conform to the anatomic papilla. After the elevation of flap, the root surface will be debrided with the use of ultrasonic scaler and curettes. It is considered that only the portion of the root exposure with loss of clinical attachment (gingival recession + probable gingival sulcus/pocket) will be instrumented. Exposed root surfaces within the areas of anatomic bone dehiscence will not be instrumented, avoid damaging connective tissue fibres still attached to the root cementum Adequate flap mobilization during coronal advancement will be ensured when the marginal gingiva of the flap is capable of reaching a level coronal to the cementoenamel junction of the tooth in the surgical area and the surgical papilla should cover the anatomic papilla Intravenous blood will be collected from patients during these procedures in 10ml glass sterile tubes without anticoagulant solutions. The samples will then be immediately centrifuged using centrifuge machine to obtain either Concentrated Growth Factor or Platelet Rich Fibrin In Group A Concentrated growth factor will be placed Group B Platelet Rich Fibrin will be placed Both Group A and Group B will receive simple interrupted sutures for the vertical incisions and sling sutures will be given to stabilize the papilla using 5-0 vicryl sutures. Post operative instructions and medications will be provided to the patient. Patients will be instructed not to brush the teeth in the operated area until further instructions Patients will be instructed to rinse with chlorhexidine digluconate (0.2%) twice daily Patients will be scheduled for a follow-up appointment after 2 weeks for further assessment The clinical parameters such as Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level, Recession Depth, Recession Width, Keratinized Gingival Width, Gingival Thickness will be measured at 3 months and 6 months postoperatively
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