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

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: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Other: phase 1 therapy chronic periodontitis; Other: Acacia catechu; Other: Low Level Laser Therapy; Other: local drug delivary acacia +LLL

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
inflammatory biomarker	Measuring Interleukin 1 beta level	0 and 6 month evaluation
Antioxidant biomarker	measuring total antioxidant capacity.	0 and 6 month evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival index	clinical evaluation of GI score from (0 to 3) 0 = normal is the best value. 3 = diseesed (the worst value). 0=Normal gingiva.; = mild inflammation, a slight change in color, slight edema, no bleeding on probing.; = moderate inflammation, redness, edema, and glazing; bleeding on probing.; = severe inflammation, marked redness and edema, ulceration, and the tendency to spontaneous bleeding.	0,1,3,6 month evaluation
clinical attachment level or loss	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	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.; = Some plaque is visible only when a probe is used to skim the tooth surface.; = A visible amount of plaque can be seen without a probe.; = abudant amount of plaque at gingival margin, interdental spaces filled with plaque.	0,1,3,6 month evaluation

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls
• Investigators: Study Director: Abeer Gawish, professor, Al-Azhar University; Study Director: mostafa hegazy, professor, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): May 19, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 30, 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 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Chronic periodontitis; Adjunctive therapy; Herbal Medicine; Low Level Laser Therapy; Acacia catechu
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Periodontitis; Chronic Periodontitis
• Other Study ID 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