| CTRI Number |
CTRI/2025/02/079883 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Immediate dental implant placement in infected sites versus delayed implant placement: A comparative study |
|
Scientific Title of Study
|
Immediate placement of dental implants in infected sites versus delayed implant placement: A 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 Ujval Patel |
| Designation |
Resident Doctor |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Department of Oral and Maxillofacial Surgery, Faculty of Dental Science, Dharmsinh Desai University, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8238083553 |
| Fax |
|
| Email |
patelujjaval14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiren Patel |
| Designation |
Professor and Head of the Department |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Department of Oral and Maxillofacial Surgery, Faculty of Dental Science, Dharmsinh Desai University, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9426034400 |
| Fax |
|
| Email |
hirenpatel.fods@ddu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ujval Patel |
| Designation |
Resident Doctor |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Department of Oral and Maxillofacial Surgery, Faculty of Dental Science, Dharmsinh Desai University, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8238083553 |
| Fax |
|
| Email |
patelujjaval14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Science, Dharmsinh Desai University, Nadiad, Gujarat, India, 387001 |
|
|
Primary Sponsor
|
| Name |
Faculty of Dental Science Dharmsinh Desai University |
| Address |
Faculty of Dental Science, Dharmsinh Desai University, College road, Nadiad,Gujarat, India, 387001 |
| Type of Sponsor |
Research institution |
|
|
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 Ujval Patel |
Faculty of Dental Science |
Department of Oral and Maxillofacial Surgery, Faculty of Dental Science, Dharmsinh Desai University, College Road, Nadiad
Kheda
GUJARAT |
8238083553
patelujjaval14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Faculty Of Dental Science Dharmsinh Desai University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Edentulous space |
dental implant placement in previously extracted site or edentulous area |
| Intervention |
Infected sites |
Extraction followed by immediate placement of dental implant in teeth which are having periapical infection or pathologies |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic periapical infected and non infected teeth.
2. Distance between the bottom of the alveolar fossa and maxillary sinus floor greater than or equal to 2 mm and a distance between the bottom of the alveolar fossa and inferior alveolar canal greater than or equal to 3 mm
|
|
| ExclusionCriteria |
| Details |
1. Acute infection of adjacent teeth or tissues
2. Untreated teeth with chronic periodontitis
3. Systemic illness and contraindicating surgical procedure
4. Long-term use of bisphosphonates |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Minimal marginal bone loss and better implant stability |
1 month, 3 months and 6 months post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Implant stability
Implant Failure |
1 year post operative |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="0"
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
|
The purpose of comparative studies on immediate versus delayed dental implant placement in infected sites is to evaluate and contrast the clinical outcomes associated with each approach. These studies aim to determine the efficacy and safety of placing implants immediately after tooth extraction in infected areas compared to waiting for a healing period before implant placement. Key outcomes assessed include implant survival rates, peri-implant bone loss, soft tissue health, complication rates, and patient satisfaction. The findings from these studies assist clinicians in making informed decisions about the optimal timing of implant placement in the presence of infection, balancing the benefits of reduced treatment time against potential risks. |