- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536451
Low-Level Diode Laser Therapy on the Acceleration of Osseointegration Around Delayed Dental Implant
April 11, 2026 updated by: Hams Hamed Abdelrahman
The Efficacy of Low-Level Diode Laser Therapy on the Acceleration of Osseointegration and Mucosal Phenotype Around Delayed Dental Implant: A Randomized Controlled Clinical Trial
Good quality soft tissue determines the possibility not only to obtain full primary wound closure during the bone defect reconstruction, but also assures effective implant treatment and stability of peri-implant condition.Moreover, it is very important to assure the proper emergence profile of the implant supported restorations, which give the opportunity to achieve the highest aesthetic appearance.
In the long-term, the correct width and thickness of the attached keratinized tissue is the key point to ensure the stable position of the mucosal line around the implant's neck.
The promising outcomes of laser on soft and hard tissue have been demonstrating in a variety of studies.
Therefore, the aim of this clinical study is to evaluate the efficacy of LLDLT on enhancing osseointegration and on the peri-implant mucosal tissue around delayed dental implants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kafr Elsheikh, Egypt
- Kafr El-Sheikh University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients are systemically medically free.
- Ability to maintain good oral hygiene as evidenced in recall visits.
- Sufficient mesiodistal and interocclusal space and have an intact buccal bone contours which does not require bone augmentation procedures.
- Adequate bone quality.
- Keratinized tissue ≥ 2mm.
- Thickness of the gingiva ≥ 1 mm.
Exclusion Criteria:
- Presence of any systemic disease that could influence the outcome of the therapy.
- Presence of any risk factor e.g.; smoker, pregnant, lactating patients or any disease affect bone healing.
- Previous history of periodontal surgical treatment in quadrant selected for the study.
- Restorations or caries in the area to be treated and non-vital tooth.
- Adjacent teeth are tilted or rotated.
- Patients taking medications known to cause affect bone quality.
- Traumatic occlusion or Para-functional habits such as clenching or bruxism.
- Participation in other clinical trials.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: With laser
|
implant placement in the posterior areas and implants will be placed with application of LLDL.
Preparation of the alveolus for delayed dental implant placement will be done and LLDL application according to manufacturer instructions
|
|
Active Comparator: Without laser
|
It includes ten patients seeking for implant placement at the posterior areas and those patients will be received their implants only without application of LLDL .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in marginal bone loss
Time Frame: 2 weeks, 1month, 2 months, and 6 months
|
To assess the change in marginal bone loss, the linear distance from a fixed reference point-typically the implant shoulder or CEJ-to the highest level of bone-to-tooth/implant contact is measured.
|
2 weeks, 1month, 2 months, and 6 months
|
|
Change in in implant stability
Time Frame: Immediately after surgery, 2 months and 6months postoperative.
|
Ostell device will be used to assess implant stability
|
Immediately after surgery, 2 months and 6months postoperative.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in bone density
Time Frame: 2 weeks, 1month, 2 months, and 6 months
|
Radiographic examination of the patients will be done firstly pre-operative then at six months follow-up period post-operative by using CBCT device
|
2 weeks, 1month, 2 months, and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Actual)
October 1, 2025
Study Completion (Actual)
October 1, 2025
Study Registration Dates
First Submitted
April 11, 2026
First Submitted That Met QC Criteria
April 11, 2026
First Posted (Actual)
April 17, 2026
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 11, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-116
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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