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CTRI Number  CTRI/2024/07/070744 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparing Two Methods for Gum Coverage Using Titanium-Enhanced Platelet Therapy 
Scientific Title of Study   Comparative evaluation of coronally advanced flap technique and Zucchelli’s technique utilizing Titanium prepared platelet rich fibrin in the treatment of multiple gingival recession A Randomized 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 Anuswara K 
Designation  PG student 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia D K Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9880744129  
Fax    
Email  anuswarakanthraj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MM Dayakar 
Designation  Professor and Head of the Department of Periodontology 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia D K Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448167427  
Fax    
Email  mmdayakar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr MM Dayakar 
Designation  Professor and Head of the Department of Periodontology 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia D K Karnataka India Pincode-574327


KARNATAKA
574327
India 
Phone  9448167427  
Fax    
Email  mmdayakar@yahoo.com  
 
Source of Monetary or Material Support  
KVG Dental College and Hospital Kurunjibag Sullia D K Karnataka India Pincode 574327 
 
Primary Sponsor  
Name  Dr Anuswara K 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia D K Karnataka India Pincode 574327 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Anuswara K  KVG Dental College and Hospital   Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia D K Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA 		 9880744129

anuswarakanthraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K060||Gingival recession,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CORONALLY ADVANCED FLAP TECHNIQUE WITH T-PRF  Surgery protocol-Before surgery, 10 ml blood is drawn, centrifuged at 3500 rpm for 15 min, and a T‑PRF clot is retrieved and prepared as a membrane. Extraoral and intraoral antisepsis is done with povidone‑iodine and 0.2% chlorhexidine gluconate. Under local anesthesia (Lignocaine HCl with 2% epinephrine 1:200,000), horizontal incisions are made at the mesial and distal line angles, connected with sulcular incisions. Vertical incisions are added for flap elevation. A full-thickness flap is elevated to the mucogingival junction, then split-thickness beyond the MGJ. The T‑PRF membrane is placed, and the flap is coronally advanced and sutured. A periodontal pack protects the site.The duration of procedure will be 40minutes.  
Intervention  ZUCHELLIS TECHNIQUE WITH T-PRF  Surgery protocol-Before surgery, 10 ml of blood is drawn and centrifuged at 3500 rpm for 15 minutes in titanium tubes, forming three layers: serum, T-PRF clot, and red blood cells. The T-PRF clot is retrieved and compressed into a membrane. The surgical area is disinfected with 2% betadine solution and local anesthesia is administered. A series of incisions connect the CEJ to the gingival margin, followed by split-thickness and full-thickness flap reflections. The interdental papilla is de-epithelialized, and the root surface is meticulously cleaned. The T-PRF membrane is positioned, sutured, and covered with a periodontal dressing to ensure proper healing. The duration of procedure will be 40minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Systemically healthy patient
Subjects with age group of 18- 50 years.
Patient with good oral hygiene after scaling and root planing
Subject with multiple gingival recession mandibular or maxillary incisors and premolars, RT1 and RT2 Recession
Periodontal pocket depth no more than a 3mm.
Patient who have agreed to participate in the study.
 
 
 
ExclusionCriteria 
Details  Smokers and alcoholics
Subjects under medication (bisphosphonate or steroid therapy) for other treatment
Subjects with bleeding disorders
Subjects who have undergone radiation therapy within the last 2years.
Pregnancy and lactating mothers.
Subjects who have undergone any invasive periodontal therapy in previous six months.
Subjects with cervical abrasion and occlusal trauma.
Subjects under anticoagulant medication
Subjects with blood- borne infections.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the treatment outcome following coronally advanced flap and zuchelli’s technique utilising t-prf .
 		 follow up from baseline ,1month,3month 
 
Secondary Outcome  
Outcome  TimePoints 

To evaluate gingival thickness ,interdental papillae height , root coverage ratio following coronally advanced flap utilising t-prf.
To evaluate gingival thickness ,interdental papillae height,root coverage ratio following zuchellis technique utilising t-prf.
 		 follow up from baseline ,1month,3month 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   10/11/2024 
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="8"
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   Gingival recession, characterized by the displacement of the marginal gingiva from its usual position on the tooth crown to levels beyond the cemento-enamel junction on the root surface, is associated with a spectrum of adverse effects, including dentine hypersensitivity, root caries, abrasion, erosion, and increased dental plaque accumulation. Consequently, there exists a need to explore and compare treatment modalities for addressing single or multiple recessions. While the conventional gold standard for recession treatment typically involves the application of connective tissue graft (CTG) in conjunction with the Coronally Advanced Flap (CAF) technique, recent modifications such as Zucchelli’s technique have emerged, offering potential advantages in terms of biology and clinical outcomes. Zucchelli’s technique, distinguished by its envelope-type flap devoid of vertical release incisions, ensures preserved blood supply and minimized scarring along the incision line, thereby mitigating some of the drawbacks associated with traditional approaches. Furthermore, the advent of autologous platelet concentrates (APCs) as promising adjunctive materials in restorative procedures has broadened treatment possibilities. The evolution from first-generation platelet-rich plasma (PRP) to second-generation platelet-rich fibrin (PRF), and subsequently to Titanium-prepared Platelet rich Fibrin (T-PRF)to third generation advanced platelet rich fibrin , underscores ongoing efforts to optimize treatment efficacy and patient outcomes. T-PRF, characterized by its similarity to Leukocyte-prf(L-PRF) in growth factor release and platelet activation, offers additional benefits owing to its enhanced hemocompatibility facilitated by the utilization of titanium tubes in its preparation. This study aims to comprehensively evaluate and compare the clinical outcomes concerning root coverage, aesthetics, sensitivity reduction, gingival marginal thickness, as well as postoperative factors including patient comfort, healing progression, and long-term stability. The intent of the present study is to generate robust evidence that informs clinical decision-making, thereby advancing the standard of care for patients presenting with gingival recession. By elucidating the relative effectiveness of these innovative techniques and materials, the study endeavors to contribute to enhanced treatment outcomes and long-term oral health for individuals afflicted with gingival recession. 
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