NCT06805292

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

December 30, 2024

Last Update Submit

January 30, 2025

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitisHerbal MedicineLow Level Laser TherapyAdjunctive therapyAcacia catechu

Outcome Measures

Primary Outcomes (2)

  • inflammatory biomarker

    Measuring Interleukin 1 beta level

    0 and 6 month evaluation

  • Antioxidant biomarker

    measuring total antioxidant capacity.

    0 and 6 month evaluation

Secondary Outcomes (3)

  • gingival index

    0,1,3,6 month evaluation

  • clinical attachment level or loss

    0,1,3,6 month evaluation

  • plaque index

    0,1,3,6 month evaluation

Study Arms (4)

Control Groupe

ACTIVE COMPARATOR

treated with non-surgical periodontal therapy and serves as a control group.

Other: phase 1 therapy chronic periodontitis

Test: Acacia gel group

ACTIVE COMPARATOR

using A. catechu gel adjunctive to non-surgical periodontal therapy

Other: Acacia catechu

Test: laser group

ACTIVE COMPARATOR

Group III: using low-level laser adjunctive to non-surgical periodontal therapy.

Other: Low Level Laser Therapy

Test: Acacia gel +laser group

ACTIVE COMPARATOR

Group IV: using A. catechu gel with low-level laser adjunctive to non-surgical periodontal therapy.

Other: Acacia catechuOther: Low Level Laser TherapyOther: phase 1 therapy chronic periodontitisOther: local drug delivary acacia +LLL

Interventions

Acacia catechuOTHER

local delivery of acacia catechu gel in patient with chronic periodontitis stage 2

Also known as: acaia catech gel, black catechu (trade name ), black cutch, cutch tree,, gel of aqueous extract of A.catechu bark
Test: Acacia gel +laser groupTest: Acacia gel group
Low Level Laser TherapyOTHER

low-level laser as an adjunctive therapy in patient with chronic periodontitis stage 2

Also known as: Biomodulation
Test: Acacia gel +laser groupTest: laser group
phase 1 therapy chronic periodontitisOTHER

patient with chronic periodontitis stage 2 will go for phase one therapy only

Also known as: phase 1 therapy (scalling +root planning)
Control GroupeTest: Acacia gel +laser group
local drug delivary acacia +LLLOTHER

pateient with chronic periodontitis treated with LLL +acacia catehu gel

Also known as: LLL +acacia catehu gel
Test: Acacia gel +laser group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mona Mansour

Cairo, 12345, Egypt

Location

Mona Mansour

Cairo, Egypt

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Abeer Gawish, professor

    Al-Azhar University

    STUDY DIRECTOR

  • mostafa hegazy, professor

    Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree student at Oral Medicine, Periodontology, Oral Diagnosis, and Oral Radiology Department, Faculty of Dental Medicine for Girls, Al-Azhar University., Principal Investigator).

Study Record Dates

First Submitted

December 30, 2024

First Posted

February 3, 2025

Study Start

September 20, 2022

Primary Completion

May 19, 2024

Study Completion

November 20, 2024

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)