Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling

NCT07719764 | Enrolling By Invitation DMC

• 1 other identifier: # 37-03-2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to compare osseodensification and conventional drilling for immediate dental implant placement in mandibular molar extraction sockets in adults requiring extraction and implant replacement. The main questions it aims to answer are: Does osseodensification improve primary and secondary implant stability compared with conventional drilling? Does osseodensification result in better clinical and radiographic peri-implant outcomes, including marginal bone loss, peri-implant bone density, probing depth, plaque and bleeding indices, during the healing period? Researchers will compare immediate implant placement performed using osseodensification drilling with immediate implant placement performed using conventional drilling to determine whether osseodensification provides superior implant stability and peri-implant tissue outcomes. Participants will: Undergo atraumatic extraction of a mandibular molar followed by immediate implant placement. Be randomly assigned to receive implant site preparation using either osseodensification or conventional drilling. Receive the same implant system and standardized surgical and prosthetic protocols. Attend scheduled follow-up visits for clinical examinations, implant stability measurements using resonance frequency analysis (ISQ), and radiographic evaluation of marginal bone loss and peri-implant bone density during healing and after prosthetic restoration.

Conditions

Immediate Dental Implant Placement; Lower Molar Requiring Extraction

Keywords

Immediate implant; osseodensification; lower molar; implant stability; conventional drilling

Outcome Measures

Primary Outcomes (1)

• Primary Implant Stability

  Implant stability, measured by the Implant Stability Quotient (ISQ) using resonance frequency analysis (RFA), assessed immediately after implant placement (primary stability) and during the follow-up period (at 3 months) to evaluate secondary stability. Implant stability will be assessed using resonance frequency analysis (RFA) with the Osstell® device. Stability will be expressed as the Implant Stability Quotient (ISQ), a unitless index ranging from 1 to 100, where higher ISQ values indicate greater implant stability. Measurements will be obtained by attaching a SmartPeg to the implant and recording ISQ values in two perpendicular directions (buccolingual and mesiodistal). The mean of the two measurements will be used for statistical analysis. Implant stability will be evaluated immediately after implant placement (baseline/primary stability), and at 3 months and 6 months postoperatively (secondary stability). The primary outcome will be the difference in mean ISQ values between the

  Day 0, and 3 months

Secondary Outcomes (6)

• Secondary Implant Stability

  3 months after implant placement

• Marginal Bone Loss (MBL)

  Baseline, 3 months, and 6 months after implant placement

• Peri-implant Bone Density

  Baseline, 3 months, and 6 months after implant placement

• Peri-implant Probing Depth (PPD)

  3 months and 6 months after implant placement

• Modified Plaque Index (mPI)

  Baseline, 3 months, and 6 months after implant placement

Study Arms (2)

osseodensification drilling group

EXPERIMENTAL

Immediate implant placement using osseodensification drilling for implant osteotomy preparation.

Procedure: Osseodensification drilling

conventional drilling protocol

ACTIVE COMPARATOR

Immediate implant placement using the conventional drilling protocol for implant osteotomy preparation.

Procedure: Conventional drilling

Interventions

Osseodensification drilling PROCEDURE

Implant osteotomy preparation was performed using the osseodensification drilling protocol with densifying burs rotating in densifying mode before immediate implant placement in mandibular molar extraction sockets.

osseodensification drilling group

Conventional drilling PROCEDURE

Implant osteotomy preparation was performed using the conventional sequential drilling protocol before immediate implant placement in mandibular molar extraction

conventional drilling protocol

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 20 years - 50 years. Patients requiring extraction of a mandibular first or second molar with immediate implant placement.
• Presence of sufficient interradicular and apical bone to achieve primary implant stability following immediate implant placement.
• Adequate bone dimensions to accommodate the planned dental implant without the need for extensive bone augmentation.
• Good oral hygiene and willingness to comply with the study protocol and follow-up visits.
• Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

• Uncontrolled systemic diseases or medical conditions contraindicating oral surgery or implant placement.
• Pregnancy or lactation. Current smokers or tobacco users. Untreated active periodontal disease or poor oral hygiene. Acute infection or extensive pathology at the implant site that would preclude immediate implant placement.
• History of radiotherapy to the head and neck region or treatment with intravenous bisphosphonates or other medications known to adversely affect bone healing.
• Bruxism or parafunctional habits likely to compromise implant success. Inability or unwillingness to attend scheduled follow-up visits or comply with study requirements.

Sponsors & Collaborators

• Dar Al Uloom University: lead

Study Sites (1)

Dar AlUloom University, College of Dentistry

Riyadh, 11512, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Periodontology and Oral Medicine, College of Dentistry

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 22, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)