Skip to main content
Clinical Trials/CTRI/2025/08/093152
CTRI/2025/08/093152
Not yet recruiting
Phase 3

Comparative Evaluation of Implant Stability and Bone Assessment in Delayed and Immediate Implant Using Conventional and Osseodensification Drilling in Maxillary Esthetic Zone: Randomised Control Trial

Dr Komal Ware1 site in 1 country36 target enrollmentStarted: August 25, 2025Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Dr Komal Ware
Enrollment
36
Locations
1
Primary Endpoint
2.secondary Implant Stability

Overview

Brief Summary

After obtaining informed consent, participants will be seated comfortably in a dental chair under aseptic precautions. The surgical site in the maxillary esthetic zone will be anesthetized using a local anesthetic. Patients will be randomly allocated into four groups: Group 1 – delayed implant placement using the conventional drilling technique; Group 2 – delayed implant placement using the osseodensification drilling technique; Group 3 – immediate implant placement using the conventional drilling technique; and Group 4 – immediate implant placement using the osseodensification drilling technique. Osteotomy will be performed according to the assigned drilling protocol. Implants of the same system and dimensions will be placed as per the preoperative assessment. Primary implant stability will be measured at the time of placement using resonance frequency analysis (RFA), and bone changes will be assessed radiographically at baseline, 3 months, and 6 months postoperatively. All patients will receive standard postoperative care and oral hygiene instructions.

This randomized controlled clinical trial aims to compare implant stability and bone changes between conventional drilling and osseodensification techniques in both delayed and immediate implant placements in the maxillary esthetic zone. A total of four groups will be studied:

  1. Group 1: Delayed implant with conventional drilling

  2. Group 2: Delayed implant with osseodensification

  3. Group 3: Immediate implant with conventional drilling

  4. Group 4: Immediate implant with osseodensification

All implants will be placed under strict aseptic conditions using standardized surgical protocols. Implant stability will be measured using resonance frequency analysis (RFA) at placement and during follow-up. Radiographic bone level assessment will be performed at baseline, 3 months, and 6 months postoperatively. The study will help evaluate the effectiveness of osseodensification in enhancing implant stability and preserving peri-implant bone in esthetic areas.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • Systemically healthy patients requiring and opting Dental Implants in maxillary Esthetic Zone 2)Sites will be Maxillary Esthetic Zone 4)Good oral hygiene and periodontal status 5)Adequate amount of bone volume at implant site allowing to perform the surgery.

Exclusion Criteria

  • Patients with systemic diseases that contraindicates the surgery, immune compromised patients.
  • Pregnant or lactating females.
  • H/o radiotherapy, smokers, parafunctional habits, acute and chronic infection.
  • Patients not willing to participate in the study or During the Study.

Outcomes

Primary Outcomes

2.secondary Implant Stability

Time Frame: Baseline,3rd Month,6th Month

1.Primary Implant Stability

Time Frame: Baseline,3rd Month,6th Month

3.Crestal bone level

Time Frame: Baseline,3rd Month,6th Month

4.Bone Density

Time Frame: Baseline,3rd Month,6th Month

Secondary Outcomes

  • Clinical soft tissue outcomes(BOP – Muhlemann’s Papillary Bleeding Index)

Investigators

Sponsor
Dr Komal Ware
Sponsor Class
Other [{Self funded}]
Responsible Party
Principal Investigator
Principal Investigator

DrKomal Ware

Government Dental College and Hospital Nagpur

Study Sites (1)

Loading locations...

Similar Trials