Evaluation of Acacia Catechu and Low-Level Laser in the Treatmentof Stage II Periodontitis (LLLvsAgel)

January 30, 2025 updated by: Mona Monsour, Faculty of Dental Medicine for Girls

Evaluation of Acacia Catechu and Low-Level Laser in the Treatment of Stage II Periodontitis

Evaluation of Acacia catechu and Low-Level Laser in the Treatment of Stage 2 Periodontitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • Assess the effectiveness of A. catechu gel (local delivery) adjunctive to non surgical therapy in the treatment of stage chronic periodontitis. Clinical and biochemical evaluation.
  • Compare the effectiveness of A. catechu gel (local delivery) and low-level laser adjunctive to non-surgical therapy in the treatment of stage chronic periodontitis.

Clinical and biochemical evaluation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
      • Cairo, Egypt, 12345
        • Mona Mansour
      • Cairo, Egypt
        • Mona Mansour

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Motivated patient with good oral hygiene.
  2. Age ranges from (30-50) years.
  3. Free from any systemic disease according to the Cornell Medical Index (16).

Exclusion Criteria:

  1. Patients who received periodontal treatment over the 12 months preceding the study.
  2. Patients who consumed antibiotics or anti-inflammatory drugs within the last 3 months.
  3. Previous or current radiation or immunosuppressive therapies.
  4. Pregnant & lactating women.
  5. Patient with orthodontic appliances. Or having partial dentures.
  6. Patient with parafunctional habits.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Groupe
treated with non-surgical periodontal therapy and serves as a control group.
Other: phase 1 therapy chronic periodontitis
patient with chronic periodontitis stage 2 will go for phase one therapy only
Other Names:
  • phase 1 therapy (scalling +root planning)
Active Comparator: Test: Acacia gel group
using A. catechu gel adjunctive to non-surgical periodontal therapy
Other: Acacia catechu
local delivery of acacia catechu gel in patient with chronic periodontitis stage 2
Other Names:
  • acaia catech gel
  • black catechu (trade name )
  • black cutch
  • cutch tree,
  • gel of aqueous extract of A.catechu bark
Active Comparator: Test: laser group
Group III: using low-level laser adjunctive to non-surgical periodontal therapy.
Other: Low Level Laser Therapy
low-level laser as an adjunctive therapy in patient with chronic periodontitis stage 2
Other Names:
  • Biomodulation
Active Comparator: Test: Acacia gel +laser group
Group IV: using A. catechu gel with low-level laser adjunctive to non-surgical periodontal therapy.
Other: phase 1 therapy chronic periodontitis
patient with chronic periodontitis stage 2 will go for phase one therapy only
Other Names:
  • phase 1 therapy (scalling +root planning)
Other: Acacia catechu
local delivery of acacia catechu gel in patient with chronic periodontitis stage 2
Other Names:
  • acaia catech gel
  • black catechu (trade name )
  • black cutch
  • cutch tree,
  • gel of aqueous extract of A.catechu bark
Other: Low Level Laser Therapy
low-level laser as an adjunctive therapy in patient with chronic periodontitis stage 2
Other Names:
  • Biomodulation
Other: local drug delivary acacia +LLL
pateient with chronic periodontitis treated with LLL +acacia catehu gel
Other Names:
  • LLL +acacia catehu gel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
inflammatory biomarker
Time Frame: 0 and 6 month evaluation
Measuring Interleukin 1 beta level
0 and 6 month evaluation
Antioxidant biomarker
Time Frame: 0 and 6 month evaluation
measuring total antioxidant capacity.
0 and 6 month evaluation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
gingival index
Time Frame: 0,1,3,6 month evaluation

clinical evaluation of GI

score from (0 to 3) 0 = normal is the best value. 3 = diseesed (the worst value).

0=Normal gingiva.

  1. = mild inflammation, a slight change in color, slight edema, no bleeding on probing.
  2. = moderate inflammation, redness, edema, and glazing; bleeding on probing.
  3. = severe inflammation, marked redness and edema, ulceration, and the tendency to spontaneous bleeding.
0,1,3,6 month evaluation
clinical attachment level or loss
Time Frame: 0,1,3,6 month evaluation
  • Clinical Attachment Level (CAL) or loss: Clinical attachment level was measured from the cementoenamel junction to the base of the pocket using a University of Michigan probe with the University of North Carolina periodontal probe (UNC15) around each tooth.
  • measurement unite by millimetre
  • zero clinical attachment level means no periodontitis
  • clinical attachment loss is a critical parameter differentiated betwwn gingivitis and periodontitis
  • the less the number, the better the case improvement.
  • cal of 2 mm is better than cal of 4 mm.
0,1,3,6 month evaluation
plaque index
Time Frame: 0,1,3,6 month evaluation

evaluation of PI score from (0-3) 0 is the best value; 3 is the worst.

0=No plaque is visible, even when a probe is used.

  1. = Some plaque is visible only when a probe is used to skim the tooth surface.
  2. = A visible amount of plaque can be seen without a probe.
  3. = abudant amount of plaque at gingival margin, interdental spaces filled with plaque.
0,1,3,6 month evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Faculty of Dental Medicine for Girls

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Abeer Gawish, professor, Al-Azhar University
  • Study Director: mostafa hegazy, professor, Al-Azhar University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OMPDR-108-1J

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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