- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05911607
PBMT Influence on Alveolar Socket Preservation
June 20, 2023 updated by: Mohamad Anwar Abd-Elhaleem Othman, Cairo University
Influence of Photobiomodulation Therapy (PBMT) as an Adjunctive Therapy in Alveolar Socket Preservation Preceding Dental Implant Placement
Goal of this study is to compare between the effect of two different low power lasers on extraction socket healing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
After molar tooth extraction, 6 Low power (PBMT) laser sessions.
Evaluation:
Visual Radiographic Histological
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
-
-
-
Cairo, Egypt, 12613
- National Institut of laser enhanced sciences
-
-
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
Yes
Description
Inclusion Criteria:
- Fit for implant rehabilitation.
- Acceptable oral hygiene.
- Willingness to attend 6 visits within 15 days of extraction.
Exclusion Criteria:
- Uncontrolled diabetes.
- Sub optimal oral hygiene.
- Heavy smoker.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Red Laser
Photobiomodulation using nm Diode.
|
Phototherapy for extraction sockets using two different lasers.
|
|
Active Comparator: Infrared Laser
Photobiomodulation using nm Diode.
|
Phototherapy for extraction sockets using two different lasers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic socket dimensions
Time Frame: 3 months
|
Alveolar Socket surface area measured on Cone Beam Computerised Tomography
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Soft tissue healing
Time Frame: 15 days
|
Landry, Turnbull, Howley healing index; scoring from 1 to 5 where 1 represents very poor healing while 5 denotes perfect healing.
|
15 days
|
|
Histological examination
Time Frame: 3 months
|
Histological examination of bone samples
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ahmed Ab Zaky, National Institute of Laser Enhanced Sciences, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
July 1, 2021
Primary Completion (Actual)
August 1, 2022
Study Completion (Actual)
September 15, 2022
Study Registration Dates
First Submitted
June 2, 2023
First Submitted That Met QC Criteria
June 20, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2905561312919
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Extraction Socket Healing
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King Abdulaziz UniversityCompletedSocket Preservation | Alveolar Ridge Preservation | Extraction Socket HealingSaudi Arabia
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