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Clinical Trials/CTRI/2025/04/085966
CTRI/2025/04/085966Not yet recruitingPhase 2/3

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

Dr Yash Zawar1 site in 1 country9 target enrollmentStarted: May 31, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
9
Locations
1
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: baseline, 15 days, 3 months and 6 months

Secondary Outcomes

  • 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)

Investigators

Sponsor
Dr Yash Zawar
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Yash Zawar

K.L.E V.K Institute of Dental science, Belgaum

Study Sites (1)

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