NCT07077915

Brief Summary

Aim of the study is to analyze and compare the characteristic differences occurring in the surrounding bone in an immediate implant placed by osseodensification to immediate implants placed with the conventional technique

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 12, 2025

Last Update Submit

July 23, 2025

Conditions

Keywords

immediate dental implantimmediate dental implant with bone graftosseodensificationconventional drillingdensah burs

Outcome Measures

Primary Outcomes (2)

  • Interradicular bone width

    The width of the interradicular bone in the interradicular septum will be measured immediately before and after drilling is performed during surgery. Measurements will be taken using a UNC-15 periodontal probe and recorded in millimeters (mm).

    Intraoperative (at time of surgery)

  • Dental implant stability

    Implant stability will be assessed using the Osstell device, which uses resonance frequency analysis to calculate an Implant Stability Quotient (ISQ). ISQ values range from 1 to 100, with higher values indicating greater implant stability.

    up to 4 months after dental implant placement

Secondary Outcomes (2)

  • Marginal Bone Level

    up to 7 months after the implantation

  • Bone density

    up to 7 months after dental implant placement

Study Arms (2)

Osseodensification burs

EXPERIMENTAL
Other: Osseodensification burs

Conventional Burs

ACTIVE COMPARATOR
Other: Conventional burs

Interventions

Densah burs are osseodensification burs used to condense bone and prepare dental implant site, unlike conventional technique which cuts and removes the bone

Osseodensification burs

Preparation of dental implant site by the Conventional technique using Conventional burs that are subtractive

Conventional Burs

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient age 25 to 45 years old
  • Systemically and periodontally healthy individuals.
  • Non-smokers or light smokers (Less than 5 cigarettes a day) (Schane 2010).
  • Good oral hygiene.
  • Healthy remaining dentition.
  • Adequate quality and quantity of bone
  • Interradicular septum ≥ 2 mm (Bleyan, 2022).
  • Mandibular non-restorable molars.
  • Type A or B socket (Smith and Tarnow, 2013).

You may not qualify if:

  • Acute inflammation or infection in the implant region.
  • Patients with mental disorders who could not cooperate with treatment or communicate normally.
  • Patients who have severe systemic disorders (Uncontrolled Diabetes, Uncontrolled Hypertension, End stage kidney or liver diseases and Severe Heart diseases) .
  • Poor oral hygiene.
  • Active periodontal disease.
  • Uncooperative patients, not willing to adhere to post-surgical instructions and follow up visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beirut Arab University

Beirut, Lebanon

Location

Related Publications (1)

  • https://omx.journals.ekb.eg/article_140845_40c7deeba68c3279a9d3dffaed37c3fd.pdf

    BACKGROUND

Related Links

Study Officials

  • Nayer Aboelsaad, Phd

    Beirut Arab Univeristy

    STUDY CHAIR
  • Rania Abdelaziz, Phd

    Beirut Arab University

    STUDY DIRECTOR
  • Hani Arakji, Phd

    Beirut Arab University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master of Science candidate in Periodontics

Study Record Dates

First Submitted

July 12, 2025

First Posted

July 22, 2025

Study Start

July 1, 2025

Primary Completion

December 23, 2025

Study Completion

December 23, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations