| CTRI Number |
CTRI/2024/01/061697 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To Check healing after teeth extraction in patients with type 2 Diabetes |
|
Scientific Title of Study
|
Comparison of Extraction Socket Healing in Patients with Type 2 Diabetes Versus Non-Diabetes:
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 Effie Edsor |
| Designation |
Senior Lecturer |
| Affiliation |
Sree Mookambika Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery
Sree Mookambika Institute of Dental Sciences.
Kulasekharam po
Kanyakumari Dist
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9488830111 |
| Fax |
|
| Email |
effieedsor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Effie Edsor |
| Designation |
Senior Lecturer |
| Affiliation |
Sree Mookambika Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery
Sree Mookambika Institute of Dental Sciences.
Kulasekharam po
TAMIL NADU
629161
India |
| Phone |
9488830111 |
| Fax |
|
| Email |
effieedsor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Effie Edsor |
| Designation |
Senior Lecturer |
| Affiliation |
Sree Mookambika Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery
Sree Mookambika Institute of Dental Sciences.
Kulasekharam po
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9488830111 |
| Fax |
|
| Email |
effieedsor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery
Sree Mookambika Institute of Dental Sciences. |
|
|
Primary Sponsor
|
| Name |
Dr Effie Edsor |
| Address |
Department of Oral and Maxillofacial Surgery
Sree Mookambika Institute of Dental Sciences.
Kulasekharam po
|
| 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 Effie Edsor |
SREE MOOKAMBIKA INSTITUTE OF DENTAL SCIENCES |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
Kanniyakumari
TAMIL NADU |
9488830111
effieedsor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extraction of teeth |
Extraction of teeth in patients listed in inclusion criteria and excluding the patients listed in exclusion criteria |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patient who consent to be part of study.
• Above 18 years of age
• Patient with type 2 diabetes and treatment under oral hypoglycaemics
• Patients indicated for dental extraction
|
|
| ExclusionCriteria |
| Details |
1• Patients unable to give consent through physical or mental disability
2• Dento-alveolar infection in relation to the pertaining tooth to be extracted.
3• Type 1 diabetes and insulin dependent
4• Type 2 diabetes; HIV/AIDS; chemotherapy; systemic steroids; irradiation to the head and neck; bisphosphonates; anticoagulant and antiplatelet treatment; and major benign or malignant pathology within the jaws.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Type 2 diabetes will not significantly affect post extraction socket healing. |
day 3 , day 7 , day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="432"
Sample Size from India="432"
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)
|
30/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective study will be performed in the Department of Oral and Maxillofacial Surgery, Sree Mookambika Institute of Dental Sciences Patients 18 years and over, indicated in the inclusion criteria of the study who report for extractions under local anaesthesia will be included in the study After obtaining consent to be a part of study, a detailed medical history will be taken Random BGL to be recorded using a glucometer Patients to be seperated into two groups Group1 : known Type 2 non-insulin dependent diabetics on oral hypoglycemic Group2: The control group without conditions known to impair healing. · The intra-alveolar extraction of erupted teeth to be performed using forceps and elevators. · Patients will be advised to contact or return to the OMFS clinic if they had any problems · Patients will be reviewed-up at day 3, day 7, day 14 for the outcome of the study · Number of delayed healing patients will be observed and recorded · Adverse outcomes will be analyzed Dentoalveolar infection Space infection Dry socket Bony sequestra |