| 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
|
|
|
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
|
|
|
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. |