FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091461 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing two bio-materials for socket preservation for delayed implant placement: A study on Platelet rich fibrin and Collagen Membrane. 
Scientific Title of Study   Evaluation of efficacy of placing delayed dental implant following “Ice-cream Cone Technique” of socket preservation using Autologous Heat Compressed Platelet-rich-fibrin (PRF) membrane with Bone Allograft compared to Collagen Membrane with Bone Allograft: 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 Research Institute, Victoria Hospital campus , City market, Bangalore, Karnataka

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 Research Institute, Victoria Hospital campus , City market, Bangalore Karnataka.


KARNATAKA
560002
India 
Phone  9449630572  
Fax    
Email  periosmitha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr shreyas kamath 
Designation  postgraduate student 
Affiliation  Government Dental College and Research Institute 
Address  Department of Periodontology, Room No. 3 Government Dental College and Resrach Institute, Victoria Hospital Campus , city market bangalore karnataka

Bangalore
KARNATAKA
560002
India 
Phone  8088690072  
Fax    
Email  kamathshreyas27@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology, Room No. 3 Government Dental College and Resrach Institute,victoria hospital campus , city market bangalore karnataka 
 
Primary Sponsor  
Name  Government Dental College And Research institute Bangalore 
Address  Department of Periodontology, Room No. 3 Government Dental College and Resrach Institute,victoria hospital campus , city market bangalore karnataka 
Type of Sponsor  Research institution and hospital 
 
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 Smitha K  Government Dental College and Research Institute, Bangalore  Department of Periodontology, Room No. 3 Government Dental College and Resrach Institute,victoria hospital campus , city market bangalore karnataka
Bangalore
KARNATAKA 		 9449630572

periosmitha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Comittee, Government Dental College and Research Institute, Begaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  type 2 extraction socket with 50% intact buccal bone plate and three intact walls following extraction  
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Delayed Implant placement following socket preservation with Autologous Heat Compressed PRF membrane with DFDBA  Participants desiring dental implant treatment and satisfying the eligibility criteria will be included n the study. Atraumatic extraction will be performed by experts (Oral Surgeon) under local anesthesia. CBCT scans and Intra-oral images of the site of interest will be taken and the socket will be thoroughly debrided before performing socket preservation procedure.Socket preservation with ice cream cone technique will be performed on the missing wall of the extraction socket using Autologous heat compressed PRF membrane. The socket is then filled with DFDBA bone graft up to the gingival margin and the top part of of the graft will be compressed to cover the opening and the socket is then sutured using hidden x suturing technique with 4-0 silk suture. 
Intervention  Delayed Implant placement following socket preservation with Commercially Available Resorbable Collagen membrane with DFDBA  Participants desiring dental implant treatment and satisfying the eligibility criteria will be included n the study. Atraumatic extraction will be performed by experts (Oral Surgeon) under local anesthesia. CBCT scans and Intra-oral images of the site of interest will be taken and the socket will be thoroughly debrided before performing socket preservation procedure.Socket preservation Procedure using ice cream cone technique will be performed on the missing wall of the Type 2 extraction socket using Resorbable Collagen Membrane. The socket is then filled with DFDBA bone graft up to two-thirds of the socket and the top part of the graft will be compressed to cover the opening and the socket is then sutured using hidden x suturing technique with 4-0 silk suture. 
Comparator Agent  Delayed Implant placement in Naturally healing socket  Participants desiring dental implant treatment and satisfying the eligibility criteria will be included n the study. Atraumatic extraction will be performed by experts (Oral Surgeon) under local anesthesia. CBCT scans and Intra-oral images of the site of interest will be taken and the socket will be thoroughly debrided. Further curettage of the socket walls will be performed to allow the socket to fill with blood up to the bony crestand suturing is done using hidden X suturing technique with 4-0 silk suture. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 ASA Physical status I & II
2 Type 2 extraction socket of non-molar tooth with at least 50 percent intact buccal bone plate and the remaining three walls are intact with adjacent teeth in good periodontal health.
 
 
ExclusionCriteria 
Details  1 Participants taking medication influences the bone metabolism and bone healing.
2 Participants with the habit of smoking.
3 Participants in which tooth is extracted due to periodontal breakdown.
4 Participants with acute infection (or presence of pus) in or close to the site intended for extraction.
5 Participants with occlusal disharmony.
6 Pregnant and Lactating mothers.
7 Participants with poor oral hygiene.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Dimensional changes (soft tissue and hard tissue) from baseline to 4 months post-operatively between 3 groups as assessed by intra-oral scanner and CBCT
2 Feasibility of placing an implant in a prosthetically driven position along with achieving the primary stability. Feasibility of implant placement is defined as “achieving primary stability following implant placement in a prosthetically guided position with 1mm of residual bone circumferentially surrounding the implant”.
 		 1 at Baseline
2 4 months after performing the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
• Dimensional changes (soft tissue and hard tissue) from baseline to 4 months post-operatively between 3 groups as assessed by intra-oral scanner and CBCT
• Feasibility of placing an implant in a prosthetically driven position along with achieving the primary stability. Feasibility of implant placement is defined as “achieving primary stability following implant placement in a prosthetically guided position with 1mm of residual bone circumferentially surrounding the implant”.
 		 4 months after socket preservation 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
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)   23/07/2025 
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)  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   Participants who satisfy the eligibility criteria will be alloted after randomisation into three groups. the first group will undergo ice cream cone technique of socket preservation with autologous heat compressed prf membrane and DFDBA bone graft. the second group will be treated with ice cream cone technique of socket preservation with resorbable collagen membrane  and dfdba bone graft. third group will be followed up to observe the natural healing of the extraction socket , the primary outcome would be to asses the change in the bucco-lingual dimension of the extraction socket following interventions in all three groups along with the assesment of feasibility of placing dental implant post socket preservation without the need for ridge augmentation procedure. clinical measurment of ridge dimensions will be made with intraoral scanner , radiographic measurement will be made with cbct. histological anlyasis of preserved socket bone and patient centered outcome in all thee groups will be assesed as secondary outcome. comparision of results will be made between all three groups. 
autologous heat compressed prf membrane has been used as barrier membrane because of its increased time of biodegradation and if the results of this study prove that autologous heat compressed membrane is as efficacious as resorbable  collagen membrane in socket preservation then it will be cost effective for patient undergoing socket preservation following extraction as the prf membrane derived from patient own blood.     
 
Close