| 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
|
|
|
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
|
|
|
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, & Abrahamâ€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. |