| 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 |
|
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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 |
|
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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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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.
|
|
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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.
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|
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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 |
| 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 |