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CTRI Number  CTRI/2025/12/099351 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparison of two natural techniques, using a small portion of your gums and blood clot, for better healing of your gums and bone, after the broken front tooth which is seen during smiling,is replaced with a fixed artificial tooth.  
Scientific Title of Study   Comparative assessment of efficacy of Free Gingival Grafts and Platelet Rich Fibrin Plugs on soft tissue and hard tissue changes in Immediate Implant Placement in the Aesthetic Zone A Randomized Controlled Clinical 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 DEBOPAM SEN 
Designation  POST GRADUATE STUDENT 
Affiliation  Vokkaligara Sangha Dental College and Hospital 
Address  Vokkaligara Sangha Dental College and Hospital,Department of Periodontology, Room number 5, 2nd Floor, Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Department of Periodontology, Room number 5, 2nd Floor,Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA
560004
India 
Phone  9748613939  
Fax    
Email  drdebopamsen@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SANDEEP J N 
Designation  READER 
Affiliation  Vokkaligara Sangha Dental College and Hospital 
Address  Vokkaligara Sangha Dental College and Hospital,Department of Periodontology,Room number 5, 2nd floor,Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Department of Periodontology,Room number 5, 2nd floor Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA
560004
India 
Phone  9748613939  
Fax    
Email  jns_2_23@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR DEBOPAM SEN 
Designation  POST GRADUATE STUDENT 
Affiliation  Vokkaligara Sangha Dental College and Hospital 
Address  Vokkaligara Sangha Dental College and Hospital,Department of Periodontology,Room number 5 ,2nd floor,Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Department of Periodontology,Room number 5 ,2nd floor Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA
560004
India 
Phone  9748613939  
Fax    
Email  drdebopamsen@gmail.com  
 
Source of Monetary or Material Support  
Vokkaligara Sangha Dental College and Hospital,Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004 
 
Primary Sponsor  
Name  DR DEBOPAM SEN 
Address  Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004 
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 DEBOPAM SEN  Vokkaligara Sangha Dental College and Hospital  Dept. of Periodontology Room number 5 2nd floor ,Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA 
9748613939

drdebopamsen@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  SYSTEMICALLY HEALTHY HUMAN VOLUNTEERS IN THE AGE GROUP OF 18 TO 65 YEARS WITH A SINGLE NON RESTORABLE TOOTH IN THE ANTERIOR REGION IN NEED OF A SINGLE IMPLANT SUPPORTED FIXED PROSTHETIC REHABILITATION 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IMMEDIATE DENTAL IMPLANT PLACEMENT ALONG WITH FREE GINGIVAL GRAFT  All surgeries will be done under local anaesthesia (with an injection of 2% lidocaine,1:100000 epinephrine). The failing tooth will be removed as atraumatically as possible by detaching the periodontal ligament from the tooth without raising a flap. The mesial and distal anatomic papillae will be maintained in place. The osteotomy site will be prepared by sequential drill protocol at 1200 rpm. An implant (i55 Conical dental implant, AB DENTAL DEVICES) will be immediately inserted sub-crestally.An intermediate-thickness (0.75mm) Free Gingival Graft (FGG) will be taken from the palate and placed between the implant sites buccal and lingual flap.The implant mount will be removed and the cover screw will be placed The graft will be sutured, and the soft tissue closed with a 6-0 polypropylene suture at the recipient site. Analgesics will be prescribed for 5-7 days. Sutures will be removed 10 days after surgery. After 3 months, the patient is recalled and a simple circular punch incision will be used to expose the implant. Healing abutment will be attached and the final restoration will be placed after 2 weeks.  
Comparator Agent  IMMEDIATE DENTAL IMPLANT PLACEMENT ALONG WITH PLATELET RICH FIBRIN  All surgeries will be done under local anaesthesia (with an injection of 2% lidocaine,1:100000 epinephrine). The failing tooth will be removed as atraumatically as possible by detaching the periodontal ligament from the tooth without raising a flap. The mesial and distal anatomic papillae will be maintained in place. The osteotomy site will be prepared by sequential drill protocol at 1200 rpm. An implant (i55 Conical dental implant, AB DENTAL DEVICES) will be immediately inserted sub-crestally.Blood will be drawn before the surgery by a venepuncture of the antecubital vein and collected in a test tube without anticoagulants. It is centrifuged as 10 ml in each tube at 3000 rpm for 10 minutes. The fibrin layer is slowly removed and separated. The PRF will be placed between the implant sites’ buccal and lingual flap. The implant mount will be removed and the cover screw will be placed. The soft tissue will be sutured with a 6-0 polypropylene suture at the site. Analgesics will be prescribed for 5-7 days. Sutures will be removed 10 days after surgery. After 3 months, the patient is recalled and a simple circular punch incision will be used to expose the implant. Healing abutment will be attached and the final restoration will be placed after 2 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  SYSTEMICALLY HEALTHY HUMAN VOLUNTEERS WITH THE FOLLOWING CRITERIA

A single hopeless/non-restorable tooth candidate for extraction in the maxillary or mandibular anteriors and premolars in need of a single implant-supported fixed prosthetic rehabilitation
The presence of the intact walls of the socket after tooth extraction.
The distance between the interdental bone crest and buccal bone crest less than or equal to 3 mm after tooth extraction.
Patient with good oral hygiene.
 
 
ExclusionCriteria 
Details  General contraindications for dental and or surgical treatments.
Inflammatory and autoimmune disease of the oral cavity.
Uncontrolled diabetes.
Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
Concurrent or previous radiotherapy of head area.
Smokers (more than 10 cigarettes a day).
Pregnancy; or lactating women.
 
 
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 
Overall clinical success and patient-reported outcomes of Free Gingival Grafts(FGG) and Platelet Rich Fibrin(PRF) around immediate dental implant placement.  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Free Gingival Grafts(FGG) on peri-implant mucosal stability around immediate dental implant placement.
To evaluate the efficacy of Platelet Rich Fibrin(PRF) on peri-implant mucosal tissue stability around immediate dental implant placement.
To evaluate the efficacy of Free Gingival grafts (FGGs) on peri-implant hard tissue characteristics following immediate dental implant placement
To evaluate the efficacy of Platelet Rich Fibrin(PRF) on peri-implant hard tissue characteristics following immediate dental implant placement.
To evaluate and compare the efficacy of Free Gingival Grafts with Platelet Rich Fibrin(PRF) on soft and hard tissue characteristics around immediate dental implant placement
 
18 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   N/A 
Date of First Enrollment (India)   01/01/2026 
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="2"
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  

Tooth loss in the aesthetic zone critically affects facial harmony and psychological well-being. Consequently, reconstruction must address both functional rehabilitation and highly demanding aesthetic expectations . Current evidence indicates that immediate implant placement at the time of tooth extraction is as predictable as placement in healed sites, while additionally offering advantages such as greater patient acceptance, reduced edentulous periods, and shorter overall treatment time . In aesthetically sensitive areas, immediate implants play a key role in preserving soft tissue contours and alveolar bone dimensions .

Following implant placement, the peri-implant mucosa that develops during healing behaves in an analogous manner to the biological width around natural teeth, forming a protective soft tissue seal . Early establishment of a stable mucosal barrier is therefore crucial for safeguarding peri-implant hard and soft tissues, especially in the aesthetic zone where tissue visibility strongly influences treatment planning and outcomes . Most dimensional changes of the alveolar ridge occur within the first three months after tooth extraction , during which marked horizontal and vertical bone loss can occur, often necessitating additional corrective procedures.

Peri-implant health is typically assessed using clinical and radiographic parameters such as bleeding on probing (BOP), probing depth (PD), and marginal peri-implant bone levels. Within this context, the presence and quality of keratinized attached mucosa (KAM) around implants has emerged as a key factor. A substantial body of literature demonstrates that a KAM width of less than 2 mm is associated with increased plaque accumulation, inflammation, soft tissue recession, and marginal bone loss. While patient-centred outcomes have been less frequently investigated, clinical experience from private periodontal practice suggests that patients report greater comfort and less pain during tooth brushing when a firm band of keratinized tissue surrounds the implant . Overall, an adequate width of KAM supports improved tissue stability, reduced peri-implant inflammation, and superior aesthetic integration.

Soft tissue augmentation around dental implants can be performed at various stages (before, during, or after implant placement) using several surgical techniques and biomaterials . Many authors recommend performing soft tissue corrective procedures before the restorative phase to reduce the risk of biological complications such as mucositis and peri-implantitis and to enhance long-term peri-implant stability . Peri-implant plastic surgery is therefore not only important for achieving optimal pink aesthetics, but also for improving patient-centered outcomes, including comfort and ease of oral hygiene

 
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