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OpenTrials
Completed

NCT Number: NCT07534826

Osseo Densification Technique and LLLT in DD Implant

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.

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Key information

Conditions

Implant Stability and Osseointegration Laser Effect Around Dental Implant

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dental medicine for Girls AlAzhar university

Cairo, 12345, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

implant placement using Densah burs

Procedure

Using only Densah burs

implantation using Densah burs with Laser biostimulation

Procedure

laser was used combined with Densah burs during implantation

Primary outcomes

  1. immediate primary implant stability

    Time frame: immediately

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

Secondary outcomes

  1. Implant stability and ossification

    Time frame: 6 months follow up

    After 6 months following up it was measured clinically using osstell

  2. Modified Plaque Index

    Time frame: after 12 months following up.

    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.

  3. Probing depth

    Time frame: after 12 months following up.

    PD measured at 6 sites per implant using a calibrated periodontal probe and expressed in mm (mean value).

  4. Modified gingival index

    Time frame: after 12 months following up.

    MGI assessed at four sites per implant and averaged. Scoring (0-3); 0= normal, 1= mild inflammation, 2= moderate inflammation, 3= severe bleeding tendency.

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Official study title

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

Acronym: laser

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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