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NCT Number: NCT06805292

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

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

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mona Mansour, Cairo, Egypt

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Acacia catechu

Other

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

Low Level Laser Therapy

Other

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

Other names: Biomodulation

phase 1 therapy chronic periodontitis

Other

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

Other names: phase 1 therapy (scalling +root planning)

local drug delivary acacia +LLL

Other

pateient with chronic periodontitis treated with LLL +acacia catehu gel

Other names: LLL +acacia catehu gel

Primary outcomes

  1. inflammatory biomarker

    Time frame: 0 and 6 month evaluation

    Measuring Interleukin 1 beta level

  2. Antioxidant biomarker

    Time frame: 0 and 6 month evaluation

    measuring total antioxidant capacity.

Secondary outcomes

  1. 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.

    • = 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.

  2. 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.

  3. 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.

    • = 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.

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Official study title

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

Acronym: LLLvsAgel

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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