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NCT Number: NCT07697209

Adjunctive Antioxidant Effect of Centella Asiatica Nanoemulsion Gel in Management of Periodontitis

The aims of the current study are:

1. Evaluation of the clinical efficacy of local delivery of nanoemulsion gel containing Centella asiatica extract as an adjunct to conventional non-surgical periodontal therapy in periodontitis patients. 2. Evaluation of the antioxidant effect of this treatment by the assessment of nuclear factor erythroid 2-related factor 2 (NrF2) and glutathione peroxidase 1 (GPX1) in the gingival crevicular fluid (GCF) samples.

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Key information

Conditions

Periodontal Diseases Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Bone Loss Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry Mansoura university, Mansoura, 35516

Al Mansurah, Egypt

About this study

Forty-five healthy patients with periodontitis and healthy subjects with healthy periodontium will be included in the current study. At the beginning of the treatment, all selected patients will be motivated about the benefit of plaque control and periodontal prophylaxis.

The participants will be selected from the Outpatient Clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University. The patients will be informed about the treatment that they will receive and steps that will be taken. This includes the possible effects or risks and other treatment options according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. The subjects must understand this explanation in broad terms. They must be legally competent to give written consent before performing any required steps. The research protocol will be presented to the ethical committee at the Faculty of Dentistry, Mansoura University, to get its approval.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 25-55 years, either sex
  • Diagnosis of periodontal health OR Stage III periodontitis (per 2017 World Workshop Classification)

Exclusion criteria

  • Known allergy or sensitivity to any component of the study medication
  • Systemic antibiotics or anti-inflammatory medications within the preceding 6 months
  • Uncontrolled diabetes mellitus
  • Cardiovascular disease
  • Rheumatoid arthritis
  • Renal disease
  • Pulmonary disease
  • Thyroid disease
  • Malignancy
  • Current smokers
  • Pregnant or lactating women
  • Unable or unwilling to comply with prescribed oral hygiene instructions

Treatment and study plan

Centella asiatica nanoemulsion gel

Drug

Following scaling and root planing, patients in Group 1 received local subgingival application of Centella asiatica nanoemulsion gel via disposable syringe with a blunt-ended cannula, applied once weekly for 3 months.

Scaling and Root Planing (SRP)

Procedure

Full-mouth scaling and root planing using ultrasonic instrumentation and Gracey curettes, plus standardized oral hygiene instructions.

Primary outcomes

  1. Plaque Index

    Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)

    Full-mouth plaque accumulation scored at the mesial, distal, buccal, and lingual/palatal surfaces of each examined tooth on a 0-3 scale, with higher scores indicating greater plaque accumulation. The participant-level score is the average of all recorded surface scores.

  2. Gingival Index

    Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)

    Gingival inflammation was scored at each examined surface on a 0-3 scale based on gingival color, consistency, and presence/absence of bleeding on probing, with higher scores indicating more severe inflammation (0 = clinically healthy gingiva, 3 = severe inflammation with marked redness, edema, ulceration, or spontaneous bleeding).

  3. Gingival Bleeding Index

    Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)

    Presence or absence of bleeding recorded following gentle probing of the gingival margin at each examined site, calculated as the number of bleeding sites divided by the total number of examined sites and expressed as a percentage. Higher percentages indicate greater gingival bleeding.

  4. Periodontal Probing Depth (PPD)

    Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)

    Distance in millimeters from the free gingival margin to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate deeper pockets and greater periodontal destruction.

  5. Clinical Attachment Level (CAL)

    Time frame: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)

    Distance in millimeters from the cemento-enamel junction to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate greater loss of periodontal attachment

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Adjunctive Antioxidant Effect of Centella Asiatica Nanoemulsion Gel in the Management of Periodontitis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

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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