- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05555420
BMP-2 and ALP Levels Following Laser Therapy With Scaling and Root Planing in Periodontitis- RCT.
September 22, 2022 updated by: Marwa El Sayed Abbas Ahmed, Cairo University
Assessment of BMP-2 and ALP Levels Following Laser Therapy as an Adjunct to Scaling and Root Planing for Treatment of Periodontitis- A Randomized Clinical Trial.
Patients with periodontitis will be treated by either SRP only or SRP in combination with laser.
Samples from GCF will be collected immediately after treatment and at 3 months follow-up time. Levels of BMP-2 and ALP will be assessed at these time points.
Statistical analysis to compare the results will be performed.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Periodontitis
Exclusion Criteria:
- Uncontrolled medical condition
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SRP only
|
Non-surgical periodontal therapy in combination with Laser
|
|
Experimental: SRP+Laser
|
Non-surgical periodontal therapy in combination with Laser
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of attachment gain
Time Frame: 3 months
|
Described in mm
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of BMP-2 in GCF
Time Frame: 3 months
|
ELISA test
|
3 months
|
|
Level of ALP in GCF
Time Frame: 3 months
|
Colorimetry
|
3 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 (Anticipated)
November 1, 2022
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
September 22, 2022
First Submitted That Met QC Criteria
September 22, 2022
First Posted (Actual)
September 26, 2022
Study Record Updates
Last Update Posted (Actual)
September 26, 2022
Last Update Submitted That Met QC Criteria
September 22, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACU-Dentistry-Perio.1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
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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