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CTRI Number  CTRI/2024/10/075171 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Autogenous Dentin graft and Xenograft for Socket preservation- A Randomized Controlled Clinical Trial 
Scientific Title of Study   Clinical, Radiographic, Histological and Histomorphometric Analysis of Socket Preservation, Comparing Autogenous dentin graft and Xenograft following an Open Membrane Technique 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  S Poojyashree 
Designation  PG student. 
Affiliation  Sri Ramachandra Institute Of Higher Education and Reseach. 
Address  Department of Periodontology, Sri Ramachandra Dental College, Porur, Chennai.

Chennai
TAMIL NADU
600116
India 
Phone  8939616515  
Fax    
Email  poojyasundar174@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Muthukumar 
Designation  Professor 
Affiliation  Sri Ramachandra Institute Of Higher Education and Reseach. 
Address  Department of Periodontology, Sri Ramachandra Dental College Porur Chennai 600116

Chennai
TAMIL NADU
600116
India 
Phone    
Fax    
Email  muthukumars@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  S Poojyashree 
Designation  PG Student 
Affiliation  Sri Ramachandra Institute Of Higher Education and Reseach. 
Address  Department of Periodontology, Sri Ramachandra Dental College, Porur Chennai

Chennai
TAMIL NADU
600116
India 
Phone  8939616515  
Fax    
Email  poojyasundar174@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra dental college, Department of Periodontology, Porur, Chennai - 600116 India  
 
Primary Sponsor  
Name  S Poojyashree 
Address  Sri Ramachandra dental college, Ramachandra nagar, Porur, Chennai - 600116 India  
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 S Poojyashree  Sri Ramachandra Dental College  Sri Ramachandra Dental College Room number 5, Department Of Periodontology, Porur, Chennai - 600116
Chennai
TAMIL NADU 
8939616515

poojyasundar174@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for students project  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, (2) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autogenous dentin graft  The extracted tooth will be placed in the dentin crusher (KometaBio grinding device).The Crushed dentin particles will be collected and placed in the Dentin cleanser solution for 5 minutes at room temperature, after which it will be dehydarated using sterile gauze. To balance the Ph, Phosphate buffered solution (PBS) will be poured into the dish containing the dentin particles, this process will be repeated to obtain Autogenous Dentin Bone graft.(300-1200 μm size) Total duration of intervention - 7 minutes.  
Comparator Agent  Xenograft (DBBM-Collagen Geistlich Bio-Oss®)   half of the selected patients will be given commercially available Xenograft Total Duration- since it is a commercially available graft material, it will be placed immediately. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age ≥ 20 years
Type I extraction socket morphology
Healthy or stable periodontal status
Teeth that is indicated for extraction due to caries, fracture, endodontic failure
Need for implant restoration at the site of extraction 
 
ExclusionCriteria 
Details  Medical and general contraindications for the surgical procedure, expressed by ASA score ≥ III (Smeets, de Jong, & Abraham‐Inpijn, 1998)
Patients with any systemic disorder known to interfere with periodontal treatment such as diabetes, coronary heart disease, Rheumatoid Arthritis, Rheumatic Fever, SLE, Malignancy, Respiratory diseases, Renal diseases, Other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.)
Presence of periodontal disease, expressed by pocket probing depths of ≥4 mm and bleeding on probing (modified sulcus bleeding index score ≥2);
Smoking
Earlier treatment with radiotherapy to the head and neck region
Pregnancy
Post-extraction bony defect
Patients on intramuscular or intravenous bisphosphonates
Allergies or sensitivity to alginate, latex, collagen or acrylic
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
New bone formation - histological and histomorphometric analysis
Horizontal ridge width and vertical bone height - Radiographic analysis
Width of keratinized gingiva - Clinical analysis
PROMS - Wound healing , Pain and patient satisfaction 
Histological , Histomorphometric and Radiographic , Clinical- Baseline, 4 months
PROMs- 5 days and 1 month
 
 
Secondary Outcome  
Outcome  TimePoints 
New bone formation - histomorphometric analysis
Width of keratinized gingiva - Clinical analysis 
Histomorphometric & Clinical- Baseline, 5 months

 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 2 
Date of First Enrollment (India)   25/10/2024 
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="2"
Months="0"
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  

A total of thirty-six patients were chosen and divided into two groups. Every patient who satisfies the requirements for inclusion will be progressively included to the experiment. Using an envelope system and a computer-generated table, each participant will be randomly assigned to receive either the TEST-I (Dentin graft) or TEST-II (DBBM-Collagen Geistlich Bio-Oss®). To assess the percentage of new bone formation by histological and histomorphometric analysis, to assess the dimensional changes of hard and soft tissues, to assess wound healing assessment using the Early Wound Healing Index (Watchel 2003) & Wound Healing Index (Landry et al., 1988), and to assess patient-centered outcomes in terms of pain and patient satisfaction, the surgical procedures for the assigned patients will be performed in the Department of Periodontology. Every patient that took part will be assesseed pain and patient satisfaction as measures of patient-centered outcomes. Prior to surgery, all study participants underwent a comprehensive diagnostic evaluation that comprised a radiograph of the afflicted area, study casts, intraoral photos, and routine blood parameter checks (FBS/PPBS, Bleeding Time (BT), Clotting Time (CT), International Normalized Ratio (INR), and platelet count). A comprehensive oral prophylaxis was then carried out. The Modified Plaque Index (Silness and Loe, 1964), the Gingival Index (Loe and Sillness, 1967), and the Modified Sulcus Bleeding Index (Mombelli et al., 1987) will be done to quantify oral hygiene at baseline for all patients prior to oral prophylaxis. Using the UNC-15 probe, the clinical width of keratinized gingiva will be assessed. The measurement of buccal bone thickness and horizontal ridge width will be based on baseline CBCT. Atraumatic tooth extraction under local anesthesia must be carried out using periotome and peizotome without opening a mucoperiosteal flap. After the socket has been completely curetted, it must be irrigated with sterile saline and examined for the presence of fenestration, dehiscence, or perforations. In the first test group, the entire socket is filled with 300–1200 μm of dentin graft. The extracted tooth will be put in the dentin crusher (KometaBio grinding device) in order to prepare the dentin graft. After being gathered and let to sit at room temperature for five minutes, the crushed dentin particles will be dehydrated using sterile gauze. In order to obtain an autogenous dentin bone graft, phosphate buffered solution (PBS) will be added to the dish containing the dentin particles in order to equalize the pH. This process will be repeated. (Size: 300–1200 μm) In test group II, all of the (DBBM-Collagen Geistlich Bio-Oss®) particles (250–1,000 μm) are entirely packed into the socket. Collagen membrane (Geistlich Bio-Gide®) is used to cover the extraction socket in both groups, and it is sutured.

 
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