Osseo Densification Technique and LLLT in DD Implant (laser)

Clinical and Radiographic Evaluation of Osseo Densification Technique Individually or Combined With Low Level Laser in Delayed Dental Implant Type IV Bone: Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Laser Effect Around Dental Implant; Implant Stability and Osseointegration
• Intervention / Treatment: Procedure: implant placement using Densah burs; Procedure: implantation using Densah burs with Laser biostimulation

Detailed Description

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 bio stimulation. Both groups were selected with Type IV bone

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12345
    • Faculty of dental medicine for Girls AlAzhar university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Implant placement using Densah burs only; 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; Using only Densah burs
Experimental: Implant placement using Densah burs combined with Laser biostimulation; 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; laser was used combined with Densah burs during implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability and ossification	After 6 months following up it was measured clinically using osstell	6 months follow up
Modified Plaque Index	Recorded at 4 surfaces per implant (Mesial, distal, buccal & lingual) and expressed as Mean value With scoring (0-3) 0= No Plaque, 1= plaque detected by probe, 2= visible plaque, 3= abundant plaque.	after 12 months following up.
Probing depth	PD measured at 6 sites per implant using a calibrated periodontal probe and expressed in mm (mean value).	after 12 months following up.
Modified gingival index	MGI assessed at four sites per implant and averaged. Scoring (0-3); 0= normal, 1= mild inflammation, 2= moderate inflammation, 3= severe bleeding tendency.	after 12 months following up.

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls
• Investigators: Study Chair: Etimad Ah shoreibah, professor, prof. of oral medicine, periodontology, Diagnosis and radiology; Study Director: lobna mo abdelaziz, lecturer, lacturer of oral medicine, perio, diagnosis and radiology

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Actual): November 20, 2025
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: dental implant; Low-Level Laser Therapy; Osseodensification
• Additional Relevant MeSH Terms: Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: OMPDR 103-2j

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: results telling which group has better healing and stability
• IPD Sharing Time Frame: 6 months
• IPD Sharing Access Criteria: using email for contacting
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes