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CTRI Number  CTRI/2025/12/098867 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   removal of teeth in controlled sugar patients  
Scientific Title of Study   Comparison of tooth Extraction socket healing in patients with type 2 diabetes under oral hypoglycemic drugs versus non diabetic a prospective comparative 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 S Sindhujadevi 
Designation  Reader 
Affiliation  Rajas Dental College and Hospital  
Address  Department of Oral and maxillofacial surgery Room no : 110 Rajas Dental College and Hospital Kavalkinaru Tirunelveli
Rajas Dental College and Hospital Kavalkinaru Tirunelveli 627105
Tirunelveli
TAMIL NADU
627105
India 
Phone  9524170007  
Fax    
Email  dr.sindhujadevi@rajasdebtalcollege.edu.in  
 
Details of Contact Person
Scientific Query  
Name  K S Shafeena Roshan 
Designation  CRRI 
Affiliation  Rajas Dental College and Hospital  
Address  Rajas Dental College and Hospital Kavalkinaru Tirunelveli 627105
Rajas Dental College and Hospital Kavalkinaru Tirunelveli 627105
Tirunelveli
TAMIL NADU
627105
India 
Phone  8637453147  
Fax    
Email  shafeenaroshan1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S Sindhujadevi 
Designation  Reader 
Affiliation  Rajas Dental College and Hospital  
Address  Department of Oral and maxillofacial surgery Room no : 110 Rajas Dental College and Hospital Kavalkinaru Tirunelveli
Rajas Dental College and Hospital Kavalkinaru Tirunelveli 627105
Tirunelveli
TAMIL NADU
627105
India 
Phone  9524170007  
Fax    
Email  dr.sindhujadevi@rajasdebtalcollege.edu.in  
 
Source of Monetary or Material Support  
Rajas Dental College and Hospital Kavalkinaru Tirunelveli Tami Nadu India- 627105  
 
Primary Sponsor  
Name  no sponsor 
Address  no sponsor 
Type of Sponsor  Other [no sponsor] 
 
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 
sindhuja devi   rajas dental college and hospital   Department of Oral and maxillofacial surgery Room no : 110 Rajas Dental College and Hospital Kavalkinaru Tirunelveli
Kanniyakumari
TAMIL NADU 		 9524170007

dr.sindhujadevi@rajasdentalcollege.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  extraction comparator - not applicable   Extractions under local anesthesia with 3-0 silk sutures. Total Duration of the study 6 months Post-op meds: Amoxicillin 500 mg TID + Aceclofenac/Paracetamol. Follow-up at 7 days to assess healing. Assessment Tool: Landry Wound Healing Index (1988). 
Comparator Agent  extraction in normal healthy persons   Extractions under local anesthesia with 3-0 silk sutures. Post-op meds: Amoxicillin 500 mg TID + Aceclofenac/Paracetamol. Follow-up at 7 days to assess healing. Assessment Tool: Landry Wound Healing Index (1988). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  -Patient who consent to be part of study.
-Patient with type 2 diabetes and treatment under oral hypoglycemics.
-Patients indicated for intra alveolar extraction.
-Range of RBS level less than 350mg slash dL, HbA1C less than 8 percentage  
 
ExclusionCriteria 
Details  -Patients unable to give consent due to physical or mental disability.
-Dental infections with local and systemic involvement.
-Type 1 diabetes and insulin dependent.
-Type 2 diabetes plus HIV slash AIDS; chemotherapy; systemic steroids; irradiation to the head and neck; bisphosphonates; anticoagulant and anti platelet treatment; and major benign or malignant pathology within the jaws.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate and quality of extraction socket healing using Landry et al wound healing index on 7th post operative day  Rate and quality of extraction socket healing using Landry et al wound healing index on 7th post operative day

Baseline of the study 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Number of patients with delayed wound healing  7 days  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
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  
Title Comparison of Tooth Extraction Socket Healing in Patients with Type 2 Diabetes under Oral Hypoglycemic Drugs versus Non-Diabetic Patients A Prospective Comparative Study

Background
Diabetes mellitus, particularly Type 2, impairs wound healing due to microvascular changes such as basement membrane thickening, reduced leukocyte migration, impaired perfusion, and tissue hypoxia. These factors may adversely affect post-surgical recovery. Since the oral cavity has unique features like high vascularity, bone turnover, and microbial presence, extraction socket healing in diabetic patients requires specific evaluation.

Aim:
To compare extraction socket wound healing between Type 2 diabetic patients on oral hypoglycemic drugs and non-diabetic patients.

Hypotheses:

Null Hypothesis: Diabetic patients have delayed wound healing compared to non-diabetic patients.

Alternate Hypothesis: No significant difference exists in healing between diabetic and non-diabetic patients.

Objectives:

Assess the association between diabetic status and extraction socket healing.

Record the number of patients reporting delayed healing within 7 days.

Methodology:

Design: Prospective comparative study.

Setting: Dept. of Oral & Maxillofacial Surgery, Rajas Dental College & Hospital.

Sample: 50 patients divided into 2 groups n is equal to 25 each

Group 1: Type 2 diabetics on oral hypoglycemics.

Group 2: Non-diabetic controls.

Inclusion: Adults (>18 yrs), HbA1c <8%, RBS <350 mg/dl, patients requiring intra-alveolar extractions.

Exclusion: Type 1 diabetes, systemic conditions affecting healing (HIV, chemotherapy, steroids, bisphosphonates, etc.).

Procedure:

Extractions under local anesthesia with 3-0 silk sutures.

Post-op meds: Amoxicillin 500 mg TID + Aceclofenac/Paracetamol.

Follow-up at 7 days to assess healing.

Assessment Tool: Landry Wound Healing Index (1988).

Statistics:

Descriptive statistics.

Intra-group comparison: Wilcoxon test.

Inter-group comparison: Mann-Whitney U test.

Significance: p<0.05.

Expected Outcome:
To determine whether controlled Type 2 diabetics under medication show delayed or comparable wound healing relative to non-diabetics after tooth extraction.

References:
Rosenberg (1990), Lioupis (2005), Aronovich et al. (2010), Landry et al. (1988).
 
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