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CTRI Number  CTRI/2024/11/076348 [Registered on: 06/11/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Sutureless technique in Implant placement 
Scientific Title of Study   Evaluation and comparison of the efficacy of autologous fibrin glue with 4-0 resorbable mono filament sutures following implant placement-a randomized 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 Ankita Priya 
Designation  M.D.S Student  
Affiliation  I.T.S Dental College ,Ghaziabad  
Address  Room no 5, Department Of Periodontology And Oral Implantology , ITS-CDSR Delhi- Meerut Road, Ghaziabad

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  7004192108  
Fax    
Email  ankitapriya_mds23_26@its.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vidya Sekhar 
Designation  Professor 
Affiliation  I.T.S DENTAL COLLEGE ,GHAZIABAD  
Address  Room No 5, Department Of Periodontology And Oral Implantology , ITS-CDSR DELHI-MEERUT Road, Ghaziabad

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9489038724  
Fax    
Email  vids1981@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rahul Chopra 
Designation  Professor 
Affiliation  I.T.S DENTAL COLLEGE ,GHAZIABAD  
Address  Room No 5, Department Of Periodontology And Oral Implantology , ITS-CDSR DELHI-MEERUT Road, Ghaziabad

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9953865327  
Fax    
Email  dr.rahulchopra@its.edu.in  
 
Source of Monetary or Material Support  
ITS Center For Dental Studies And Research ,Ghaziabad 
 
Primary Sponsor  
Name  Dr Ankita Priya 
Address  Department Of Periodontology And Oral Implantology ,ITS-CDSR,DELHI-MERRUT Road,201206 Ghaziabad 
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 Ankita Priya  Department Of Periodontology And Oral Implantology   Room no 5, I.T.S Dental College and Hospital. DELHI-MEERUT ROAD, GHAZIABAD, UTTAR PRADESH
Ghaziabad
UTTAR PRADESH 
7004192108

ankitapriya_mds23_26@its.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ITS INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  autologous fibrin glue  10 ml of patient blood was collected in sterile 0.9% sodium citrate containing vacutainers for autologous fibrin glue preparation and centrifuged at 3000 rpm for 10 min. This vacutainer now had a top layer of platelet-poor plasma, a middle layer of platelet-rich plasma, and the bottom fraction of red blood cells. The platelet-poor and platelet-rich plasma were aspirated into a sterile syringe and kept in another test tube without anticoagulant. RBC fraction was discarded. Protamine sulfate 10 mg/ml was added to platelet-rich and platelet-poor plasma for precipitation of maximum quantity of fibrinogen. This test tube was centrifuged at 1000 rpm for 5 min. The centrifuged tube contained a top layer of serum with thrombin (autologous) and the bottom part of fibrinogen precipitate. The top serum was discarded, retaining 0.5 ml of it in the test tube to dilute fibrinogen precipitate and was then aspirated into a separate syringe. Another syringe of calcium chloride-0.025 mmol/l was loaded, and both solutions in equal quantities mixed. The AFG will be placed in the site of implant placement and flaps will be held under digital pressure for 3 minutes.  
Comparator Agent  suture  4-0 resorbable monofilament suture 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients with adequate oral hygiene status.
2.No active periodontal disease present.
3.Patients requiring the replacement of one or more non-restorable teeth with sufficient bone volume will be selected for the study.
4.Patients willing to provide informed consent and maintain adequate oral hygiene.
5.Patients with good compliance to attend follow-ups.
 
 
ExclusionCriteria 
Details  1.Patients with uncontrolled systemic diseases that might preclude the use of dental implants.
2.Patients with autoimmune diseases or psychiatric disorders.
3.Patients undergoing or who have undergone radiation therapy and chemotherapy to the head and neck region within the last 12 months.
4.Patients with poor oral hygiene.
5.Alcoholics, drug abusers, or heavy smokers.
6.Pregnant or lactating women.
7.Insufficient bone volume or damage to the cortical plate after extraction.
8.Patients who are unable to provide informed consent at the time of the procedure.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Wound Healing Index
2. Histological characteristics of wound Healing
3. Crestal bone levels 
Wound healing index- 1,7,30 days
histological characteristics of wound healing- 90 days
Crestal bone levels- day 0 and 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. wound healing characterstics by punch biopsy
2. crestal bone levels 
at baseline and 3 months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   15/11/2024 
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="0"
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  

Traditional sutures in dentistry, while commonly used for intraoral wound closure, have several drawbacks, including tissue trauma, food debris accumulation, and potential for stitch abscess due to improper removal. These issues, coupled with patient discomfort, have driven the need for alternative closure methods. Tissue adhesives, such as fibrin sealants, cyanoacrylates, and collagen-based compounds, have emerged as viable options. These adhesives create a strong bond between wound edges, preventing separation, and are easier to apply. However, some tissue adhesives, like cyanoacrylates, have toxic degradation products that pose risks, making them less favorable. Fibrin glue, introduced in the 1940s, is commonly used but has limitations, including the risk of allergic reactions and viral transmission from its bovine-derived components. Commercial fibrin glue is also expensive. Autologous fibrin glue (AFG), derived from the patient’s own blood, addresses these issues by reducing the risk of infection, promoting faster healing, and being cost-effective. AFG also supports cell growth, differentiation, and acts as a scaffold for bone regeneration, making it a promising alternative to sutures. The study aims to evaluate and compare the efficacy of autologous fibrin glue with 4-0 resorbable monofilament sutures after implant placement. The study, conducted at the Department of Periodontology and Oral Implantology, I.T.S. Centre for Dental Studies and Research, will be a randomized clinical trial comparing autologous fibrin glue (AFG) and 4-0 resorbable monofilament sutures for wound closure following implant placement. A total of 24 edentulous sites will be randomly assigned to either AFG (Group 1) or sutures (Group 2). Participants, aged 18-65, with adequate oral hygiene and sufficient bone volume, will be included, while those with systemic diseases, poor oral hygiene, or other contraindications will be excluded. Clinical parameters, such as flap stability, wound healing indices, and pain perception, will be assessed along with radiographic evaluations of crestal bone levels. Histological analysis of wound healing characteristics will also be performed. Before surgery, patients will undergo scaling, root planing, and CBCT scans, followed by implant placement with either AFG or sutures. AFG will be prepared from the patient’s own blood using a modified method involving centrifugation and mixing with calcium chloride. The study aims to assess the efficacy of AFG in improving wound healing and tissue adaptation around dental implants.

 
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