- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06764732
Socket Seal Surgery
January 3, 2025 updated by: Nora Abdelgawad Mohamed, Al-Azhar University
Laser Assisted Socket Seal Surgery Using Bioactive Glass for Dental Implant Site Development
laser photo biomodulation (PBM) as a supplement to socket seal surgery
Study Overview
Status
Completed
Conditions
Detailed Description
the role of PBM therapy as an adjunct for bioactive glass graft in SSS approaches
Study Type
Interventional
Enrollment (Actual)
45
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
-
-
-
Dakahlia, Egypt
- , Faculty of Oral and Dental Medicine, Delta University for Science and Technology (DU), Dakahlia, Egypt
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Presence of at least a periodontal-affected and non-restorable tooth in posterior region (Class II sockets).
- At least 10% plaque control scoring was accepted
- A moderate to thick gingival phenotype
Exclusion Criteria:
- systemic diseases or conditions that may compromise healing or bone metabolism,
- having a history of radiotherapy, chemotherapy or bisphosphonate therapy, previous use of antibiotics in the last 3
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: control group
platelet rich fibrin membrane
|
10 ml of blood was withdrawn from the patient and immediately centrifuged for 10 minutes at 3000 revolutions/min and the layer of fibrin clot was obtained
|
|
Experimental: test 1 group
bioactive glass
|
10 ml of blood was withdrawn from the patient and immediately centrifuged for 10 minutes at 3000 revolutions/min and the layer of fibrin clot was obtained
supplied as resorbable form, (400-800um) particle siz
|
|
Active Comparator: test 2group
bioactive glass and Photobiomodulation
|
10 ml of blood was withdrawn from the patient and immediately centrifuged for 10 minutes at 3000 revolutions/min and the layer of fibrin clot was obtained
supplied as resorbable form, (400-800um) particle siz
The used laser parameters were set as: wavelength, 980 nm; power, 0.55 W; energy, 36 J; power density, 0.76 W cm2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
alveolar ridge dimensional changes in height and width measures
Time Frame: at base line and after 9 months
|
at base line and after 9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
bone biopsy
Time Frame: after 9 months
|
after 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Helpful Links
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)
November 10, 2022
Primary Completion (Actual)
November 10, 2023
Study Completion (Actual)
February 10, 2024
Study Registration Dates
First Submitted
January 3, 2025
First Submitted That Met QC Criteria
January 3, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 3, 2025
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Agents
- Membrane Transport Modulators
- Adrenergic Agents
- Central Nervous System Stimulants
- Dopamine Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Dopamine Agents
- Adrenergic Uptake Inhibitors
- Sympathomimetics
- Methamphetamine
Other Study ID Numbers
- DU:024100558
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.
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