Clinical & Biochemical Evaluation of Antioxidant Vs. Chlorhexidine as an Adjunctive to Non-Surgical Treatment of Stage II-grade B Periodontitis

NCT07801417 | Active Not Recruiting

• 1 other identifier: OMPDR-105-1w
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aims to evaluate and compare the clinical and biochemical effects of an antioxidant agent and chlorhexidine when used as adjuncts to non-surgical periodontal therapy in patients with Stage II Grade B periodontitis. Eligible participants will receive scaling and root planing (SRP) and will be randomly assigned to either the antioxidant or chlorhexidine treatment group. Clinical periodontal parameters, including plaque index, gingival index, probing depth, and clinical attachment level, will be assessed at baseline and follow-up visits. Biochemical analysis of inflammatory markers, including tumor necrosis factor-alpha (TNF-α) and interleukin-1 (IL-1), will be performed to evaluate the inflammatory response to treatment. The study aims to determine whether antioxidant therapy provides comparable or superior benefits to chlorhexidine as an adjunct to non-surgical periodontal treatment.

Conditions

Stage II Grade B Periodontitis

Outcome Measures

Primary Outcomes (2)

• Gingival Crevicular Fluid (GCF) Level of Interleukin-1 (IL-1)

  Changes in the concentration of Interleukin-1 (IL-1) in gingival crevicular fluid (GCF) will be assessed before and after the intervention using an enzyme-linked immunosorbent assay (ELISA) with unit of measurement pg/mL .

  Baseline to 6 months after treatment

• Gingival Crevicular Fluid (GCF) Level of Tumor Necrosis Factor-alpha (TNF-α)

  Changes in the concentration of Tumor Necrosis Factor-alpha (TNF-α) in gingival crevicular fluid (GCF) will be assessed before and after the intervention using an enzyme-linked immunosorbent assay (ELISA) with unit of measurement pg/mL .

  Baseline and 6 months after treatment

Secondary Outcomes (4)

• Probing Depth (PD)

  Baseline to 6 months after treatment.

• Gingival Index (GI)

  baseline to 6 months after treatment

• Clinical Attachment Level (CAL)

  baseline to 6 month after treatment

• Plaque Index (PI)

  baseline to 6 month after treatment

Study Arms (4)

Perioscience Gel + SRP

EXPERIMENTAL

Participants receive scaling and root planing (SRP) followed by local application of antioxidant gel.

Drug: Perioscience Gel

Chlorhexidine Gel + SRP

EXPERIMENTAL

Participants receive scaling and root planing (SRP) followed by local application of chlorhexidine gel.

Drug: High Cure Chlorhexidine Gel

Antioxidant Gel + Chlorhexidine Gel + SRP

EXPERIMENTAL

Participants receive scaling and root planing (SRP) followed by local application of both antioxidant gel and chlorhexidine gel.

Drug: High Cure Chlorhexidine Gel + Perioscience Gel

SRP Alone

ACTIVE COMPARATOR

Participants receive scaling and root planing (SRP) only, without adjunctive gel application.

Procedure: Scaling and Root Planing (SRP)

Interventions

Perioscience Gel DRUG

Local application of Perioscience antioxidant gel into periodontal pockets following scaling and root planing (SRP).

Perioscience Gel + SRP

High Cure Chlorhexidine Gel DRUG

Local application of High Cure chlorhexidine gel into periodontal pockets following scaling and root planing (SRP).

Chlorhexidine Gel + SRP

High Cure Chlorhexidine Gel + Perioscience Gel DRUG

Local application of both High Cure chlorhexidine gel and Perioscience gel into periodontal pockets following scaling and root planing (SRP).

Antioxidant Gel + Chlorhexidine Gel + SRP

Scaling and Root Planing (SRP) PROCEDURE

Conventional full-mouth scaling and root planing performed using ultrasonic and hand instruments.

SRP Alone

Eligibility Criteria

• Age: 25 Months - 40 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients diagnosed as having stage II periodontitis (22) 2- Clinical attachment loss ranged from 3-4mm 3- Radiographic bone loss ranged from 15% to 30%, mostly horizontal 4- Male or female aged from 25 - 40 years old

You may not qualify if:

• \- 1- Smoking patient 2- Pregnancy and breastfeeding patients. 3- Patients with systemic conditions which could affect the outcome of periodontal therapy.
• Previous periodontal therapy in last 6 month.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Alazhar University

Cairo, Cairo Governorate, 11651, Egypt

Location

MeSH Terms

Interventions

Tooth Exfoliation; Root Planing

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Researcher

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: September 3, 2026
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08

Locations

EG (1)