Osseo Densification Technique and LLLT in DD Implant

NCT07534826 | Completed

• 1 other identifier: OMPDR 103-2j
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A comparative clinical study on 16 patients with Type IV bone, divided into two groups (n=8): implants placed using Densah burs only versus Densah burs combined with laser bio stimulation, to evaluate implant stability and healing.

Conditions

Implant Stability and Osseointegration; Laser Effect Around Dental Implant

Keywords

dental implant; Osseodensification; Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• immediate primary implant stability

  Immediate primary implant stability was assessed through the measurement of insertion torque. The unit of measurement is (N.cm)

  immediately

Secondary Outcomes (4)

• Implant stability and ossification

  6 months follow up

• Modified Plaque Index

  after 12 months following up.

• Probing depth

  after 12 months following up.

• Modified gingival index

  after 12 months following up.

Study Arms (2)

Implant placement using Densah burs only

ACTIVE COMPARATOR

all patient's surgeries to receive dental implants were placed using only Densah burs, all patients were selected with type IV Bone. Device used was Densah kit system

Procedure: implant placement using Densah burs

Implant placement using Densah burs combined with Laser biostimulation

EXPERIMENTAL

Surgeries for Implant placement using Densah burs combined with Laser biostimulation Using Densah Kit system as a devices and Low level laser biostimulation

Procedure: implantation using Densah burs with Laser biostimulation

Interventions

implant placement using Densah burs PROCEDURE

Using only Densah burs

Implant placement using Densah burs only

implantation using Densah burs with Laser biostimulation PROCEDURE

laser was used combined with Densah burs during implantation

Implant placement using Densah burs combined with Laser biostimulation

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Missing premolar and molar maxillary area with type IV bone density, (based on CBCT and number of Hounsfield units (HU).
• Patients age should be in the range from 30 up to 60 years old.
• Free from any systemic conditions and no previous drug affect bone metabolism.

You may not qualify if:

• Smoking
• Pregnant women
• Patients in variation in anatomical landmarks
• Patients with psychological problems
• Patients with bad oral hygiene
• Patients with parafunction habits.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Faculty of dental medicine for Girls AlAzhar university

Cairo, 12345, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Etimad Ah shoreibah, professor

  prof. of oral medicine, periodontology, Diagnosis and radiology

  STUDY CHAIR

• lobna mo abdelaziz, lecturer

  lacturer of oral medicine, perio, diagnosis and radiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessor and statistical analysis helper
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of oral medicine and periodontology

Model Details: This study was designed as a comparative clinical trial involving two groups of patients receiving dental implants. A total of 16 patients are included, divided equally into two groups (n=8 each). * Group 1: Implant placement using Densah burs only. * Group 2: Implant placement using Densah burs combined with laser biostimulation.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 16, 2026
• Study Start: October 20, 2023
• Primary Completion: November 20, 2025
• Study Completion: April 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months
• Access Criteria: using email for contacting

Locations

EG (1)