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

NCT07697209 | Completed

• 1 other identifier: M0602025OM
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of the current study are:

1. 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. 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.

Conditions

Periodontal Diseases; Periodontal Bone Loss

Keywords

drug delivery; Centella Asiatica Nanoemulsion

Outcome Measures

Primary Outcomes (5)

• Plaque Index

  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.

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

• Gingival Index

  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).

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

• Gingival Bleeding Index

  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.

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

• Periodontal Probing Depth (PPD)

  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.

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

• Clinical Attachment Level (CAL)

  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

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

Study Arms (3)

group I treated with C. asiatica nanoemulsion as an adjunct to SRP

EXPERIMENTAL

Group I (study group): 15 Patients with periodontitis Stage III will be treated with C. asiatica nanoemulsion as an adjunct to SRP.

Drug: Centella asiatica nanoemulsion gel; Procedure: Scaling and Root Planing (SRP)

Group II (positive control group) treated with SRP

ACTIVE COMPARATOR

Group II (positive control): 15 patients with periodontitis Stage III will be treated with scaling and root planing (SRP) alone, with no adjunctive gel application.

Procedure: Scaling and Root Planing (SRP)

Group III (negative control group): no intervention

NO INTERVENTION

Group III (negative control/healthy control): 15 periodontally healthy participants who will receive no active periodontal intervention; assessed at baseline only

Interventions

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.

group I treated with C. asiatica nanoemulsion as an adjunct to SRP

Scaling and Root Planing (SRP) PROCEDURE

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

Group II (positive control group) treated with SRP; group I treated with C. asiatica nanoemulsion as an adjunct to SRP

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

faculty of dentistry Mansoura university, Mansoura, 35516

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Alveolar Bone Loss

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Majed M Alshammari, bachelor

  faculty of dentistry Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: July 13, 2026
• Study Start: March 21, 2025
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)