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Clinical Trials/CTRI/2024/03/064613
CTRI/2024/03/064613Not yet recruitingPhase 4

Osseodensification vs Piezo Assisted Osseodensification: A Randomized clinical trial

Rajas Dental College and Hospital1 site in 1 country32 target enrollmentStarted: April 15, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
32
Locations
1
Primary Endpoint
Piezoelectric surgery assisted split and osseodensification may exhibit stable crestal bone levels compared to osseodensification protocol where an apparent level of bone loss may be found

Study Overview

Brief Summary

Introduction: Dental implant treatment for replacing missing teeth has become very common. However, periodontal disease could also be a reason for tooth loss which leads to deficient bony architecture. Implant placement in such situations becomes possible by bone augmentation procedures like ridge split, bone expansion.

Aim: The aim of the present study is to compare and evaluate the marginal bone level around dental implants placed using osseodensification alone with that of Piezo assisted osseodensification in severely atrophied ridge.

Materials and methods: 32 patients with severely atrophied single or multiple edentulous areas in maxillary arch who are willing for dental implant placement will be included in the study. Patients will be categorized into 2 groups. Group A: implant placement using osseodensification protocol with contour grafting. Group B: implant placement using piezo assisted osseodensification protocol with grafting on jumping space. All the implants will be placed at equi-crestal level. Follow up CBCTs will be taken for all the patients to evaluate peri-implant bone levels after 18 months of implant placement.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Severely atrophic isolated maxillary ridge Cawood-Howell class 4 classification.

Exclusion Criteria

  • Patients with systemic diseases like diabetes mellitus, cardiac problems.

Outcomes

Primary Outcomes

Piezoelectric surgery assisted split and osseodensification may exhibit stable crestal bone levels compared to osseodensification protocol where an apparent level of bone loss may be found

Time Frame: CBCT will be assessed on Baseline, 4 months and 18 months

Secondary Outcomes

  • Not applicable(not applicable)

Investigators

Sponsor
Rajas Dental College and Hospital
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Renganath Murugan Jeyasree

Rajas Dental College and Hospital

Study Sites (1)

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