The Effect of an Antioxidant Gel Compared to Chlorhexidine Gel During the Soft Tissue Healing Process: A Randomized Controlled Clinical Trial

NCT06894667 | Active Not Recruiting Phase 4

• 1 other identifier: HSC_816
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the comparative impact of chlorhexidine and antioxidant gel on postoperative biomarkers following SRP. By examining biomarkers related to inflammation, oxidative stress, and tissue healing, this research seeks to determine which treatment modality more effectively supports recovery and reduces postoperative complications. Understanding the differential effects of these interventions on postoperative biomarkers will contribute valuable insights into optimizing SRP outcomes. Correlations between biomarker levels and clinical outcomes, such as periodontal pocket depth and clinical attachment level changes will provide valuable information on the clinical relevance of the findings. This comparison will also guide clinicians in selecting the most appropriate postoperative care to enhance patient recovery and long-term periodontal health.

Conditions

Periodontal Diseases

Keywords

Antioxidant; Scaling and root planing

Outcome Measures

Primary Outcomes (10)

• Plaque Index

  to assess plaque accumulation

  baseline

• Plaque Index

  to assess plaque accumulation

  at 1 month post-intervention

• Gingival index

  for evaluating gingival inflammation

  baseline

• Gingival index

  for evaluating gingival inflammation

  at 1 month post-intervention

• Probing pocket depth (PPD)

  for measuring disease severity.PPD is measured in millimetres

  baseline

• Probing pocket depth (PPD)

  for measuring disease severity. PPD is measured in millimetres

  at 1 month post-intervention

• Clinical attachment level

  o Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

  baseline

• Clinical attachment level

  Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

  at 1 month post-intervention

• Bleeding on probing (BoP)

  to assess disease activity

  baseline

• Bleeding on probing (BoP)

  to assess disease activity

  at 1 month post-intervention

Secondary Outcomes (4)

• TNF-α salivary levels

  baseline

• TNF-α salivary levels

  1 month post intervention

• MPO salivary levels

  baseline

• MPO salivary levels

  1 month post intervention

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

A local gel containing 0.5% chlorhexidene (Curaprox Perioplus Focus Gel,PERIOPLUS+ FORTE, Curaprox, Curaden) would be administered

Drug: Antimicrobial gel

Test Arm

EXPERIMENTAL

Commercially available antioxidant gel with Tea Tree oil (Tebodont®, Dr. Wild \& Co. AG, Basel) would be administered

Drug: Antioxidant gel

Interventions

Antioxidant gel DRUG

An intraoral gel containing Tea Tree oil (Tebodont®, Dr. Wild \& Co. AG, Basel) would be applied to the gingival pockets after scaling and root planing

Also known as: Tea Tree oil (Tebodont®, Dr. Wild & Co. AG, Basel)

Test Arm

Antimicrobial gel DRUG

An intraoral gel containing 0.5% Chlorhexidine (PERIOPLUS+ FORTE, Curaprox, Curaden) would be applied to the gingival pockets after scaling and root planing

Also known as: Chlorhexidine gel (PERIOPLUS+ FORTE, Curaprox, Curaden)

Control Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Stage 3 or 4 periodontitis would be invited to participate in this study.
• The following parameters will be used for the diagnosis of periodontitis: (a) presence of bleeding on gentle probing; (b)probing depth (PD) \>6mm; and (c) marginal bone loss (MBL) of at least 3.

You may not qualify if:

• Patients will be excluded from the study if they present with gingivitis alone, are currently using oral contraceptives, have systemic conditions such as diabetes or cancer, or are smokers (including those who quit within the past 6 months).
• Recent antibiotic use within the last 3 months, NSAID or bisphosphonate use within the last 90 days, and any use of chlorhexidine in the past 6 months.

Sponsors & Collaborators

• Kuwait University: lead

Study Sites (1)

Faculty of Dentistry

Kuwait City, 13110, Kuwait

Location

Related Publications (3)

• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

  PMID: 32383274 RESULT

• Martin BJ, Campbell PM, Rees TD, Buschang PH. A randomized controlled trial evaluating antioxidant-essential oil gel as a treatment for gingivitis in orthodontic patients. Angle Orthod. 2016 May;86(3):407-12. doi: 10.2319/041515-251.1. Epub 2015 Aug 17.

  PMID: 26280662 RESULT

• San Miguel SM, Opperman LA, Allen EP, Svoboda KK. Use of antioxidants in oral healthcare. Compend Contin Educ Dent. 2011 Nov-Dec;32(9):E156-9.

  PMID: 23627309 RESULT

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Tea Tree Oil

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oils, Volatile; Oils; Lipids; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants would be blinded to the intervention and the outcome assessors would also not know the group to which the participant belonged.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A total of 40 subjects would be divided into two groups: Group-1(Control): administration of chlorhexidine gel (n=20) and Group-2 (Test): administration of antioxidant gel (n=20).

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 25, 2025
• Study Start: November 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)