| CTRI Number |
CTRI/2025/04/085966 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Crestal Bone Loss and Bone Density Changes in Early vs. Delayed Implant Loading for Single Missing Posterior Mandibular Tooth: A Split-Mouth Clinical Study. |
|
Scientific Title of Study
|
Comparative evaluation of crestal bone loss and bone density changes with early and delayed loading of implants for rehabilitation of single missing posterior mandibular tooth-
A split-mouth in-vivo 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 Yash Zawar |
| Designation |
Postgraduate |
| Affiliation |
K.L.E V.K Institute of Dental science, Belgaum |
| Address |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
8830133066 |
| Fax |
|
| Email |
zawar.yash13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghunath Patil |
| Designation |
Professor |
| Affiliation |
K.L.E V.K Institute of Dental science, Belgaum |
| Address |
Department of Prosthodontics and Crown and bridge, K.L.E V.K Institute of Dental science, Nehru nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
7829910231 |
| Fax |
|
| Email |
raghunathpatil1@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghunath Patil |
| Designation |
Professor |
| Affiliation |
K.L.E V.K Institute of Dental science, Belgaum |
| Address |
Department of Prosthodontics and Crown and bridge, K.L.E V.K Institute of Dental science, Nehru nagar, Belgaum
KARNATAKA
590010
India |
| Phone |
7829910231 |
| Fax |
|
| Email |
raghunathpatil1@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Yash Zawar |
| Address |
Department of prosthodontoc crown and bridge, Department of Prosthodontics and Crown and bridge, K.L.E V.K Institute of Dental science, Nehru nagar, Belgaum, KARNATAKA, 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 Yash Zawar |
KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar |
Department number 3,
Department of
prosthodontoc crown
and bridge, second
floor. Belgaum
KARNATAKA
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
8830133066
zawar.yash13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethical Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed loading |
3 months postoperative loading will be done |
| Intervention |
Early loading |
15 days postoperative loading of the implant will be don |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient requiring replacement of single missing teeth in posterior mandible on either side
Patients in the age group of 20-65 years of either sex
Patient with good oral hygiene
Bone height of more than or equal to 10mm and bone width of more than or equal to 3.5mm to accommodate dental implant
Co-operative patient, willing for surgery and proper follow-up
Opposing natural dentition must be present
|
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions
Patients with poor oral hygiene
Patients with insufficient bone height and width
Patients who have any parafunctional habits
Patients suffering from periodontal diseases
Patients with a history of alcohol, drug dependency, smoking and poor health
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the changes in peri-implant crestal bone level and bone density for rehabilitation of single missing posterior mandibular tooth with implants in split-mouth cases using early and delayed loading protocol |
baseline, 15 days, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the changes in peri-implant crestal bone level and bone density for rehabilitation of single missing posterior mandibular tooth with implants in split-mouth cases using early and delayed loading protocol |
baseline, 15 days, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="9"
Sample Size from India="9"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2025 |
| 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="1"
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
|
Dental implants can fulfil most of the aforementioned goals. The success of dental implants depends on meticulous pre-operative treatment planning, appropriate surgical protocol, regular follow-up and an eventful healing phase to achieve osseointegration These implants can be loaded mainly using three loading protocols, namely immediate loading (within 1 week), early loading (between 1 week and 2 months) and delayed or conventional loading (after 2 months) Studies done till date have compared the effects of early and delayed loading protocols on two different groups of patients, one group has been rehabilitated with early loading protocols and other with delayed loading protocols.
The present split-mouth in vivo study is designed, to compare the effects of early and delayed loading of dental implants on peri-implant crestal bone level and bone density changes in the same patient.
|