| CTRI Number |
CTRI/2025/04/084828 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical and radiographic Comparison of delayed and immediate implants: a clinicoradiographic study |
|
Scientific Title of Study
|
Comparative evaluation of marginal bone loss and width of keratinized tissue in immediate vs delayed, platform matching implants placed subcrestally |
| 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. Harleen Jolly |
| Designation |
Post graduate |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University) |
| Address |
Room No. 7, Department of Periodontology, MMCDSR, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9810655844 |
| Fax |
|
| Email |
harleen.jolly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surinder Sachdeva |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University) |
| Address |
Department of Periodontology, MMCDSR, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8199980802 |
| Fax |
|
| Email |
sksperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surinder Sachdeva |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University) |
| Address |
Department of Periodontology, MMCDSR, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8199980802 |
| Fax |
|
| Email |
sksperio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar College of Dental Sciences and Research |
|
|
Primary Sponsor
|
| Name |
Harleen Jolly |
| Address |
Hostel 8, Maharishi Markandeshwar deemed to be university mullana ambala haryana 133207 |
| 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 Harleen Jolly |
Maharishi Markandeshwar College of Dental Sciences and Research |
department of periodontology room 7
Ambala
HARYANA |
09810655844
harleen.jolly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar (Deemed to be) University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
health human volunteers with single missing teeth or requiring extraction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed implant |
Measuring marginal bone loss and width of keratinized tissue in delayed implant |
| Intervention |
Immediate implant |
Measuring marginal bone loss and width of keratinized tissue in immediate implant |
|
|
Inclusion Criteria
|
| Age From |
26.00 Year(s) |
| Age To |
78.00 Year(s) |
| Gender |
Both |
| Details |
1 Age more than 18 years
2 Both males and females were included
3 Systemically healthy cooperative patients
4 Patients requiring implants either 3 months or more after extraction or immediately after extraction
5 Full mouth plaque score and full mouth bleeding score more than 30 percent
|
|
| ExclusionCriteria |
| Details |
1 Patients having any adverse habits like smoking or alcohol consumption.
2 Pregnant or lactating women.
3 Uncontrolled systemic disease.
4 Allergy or hypersensitivity to any product used.
5 Mental or physical disorder.
6 Medications interfering with bone metabolism.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparing marginal bone level and keratinized mucosa width in delayed and immediate implant |
Baseline and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="6"
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 the study was to compare and evaluate the clinical and radiographic parameters in delayed and immediate implants at baseline and at 6 months after prosthesis. The null hypothesis was that there was no significant difference between delayed and immediate implants. |