Efficacy of Thyme Honey as a Novel Adjunct to Non-surgical Periodontal Therapy

NCT06201975 | Unknown DMC

• 1 other identifier: 23-062
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Periodontal diseases are disease processes involving the periodontium, a term used to describe the supportive apparatus surrounding the tooth, which includes the gingival tissue, alveolar bone, cementum, and periodontal ligament. Thyme honey, as a conventional therapy, might be a novel antioxidant to abate many of the diseases directly or indirectly associated with oxidative stress. To the best of the researchers' knowledge, there are no published studies on the management of periodontitis in using locally delivered Thyme honey.

Conditions

Periodontal Diseases

Keywords

Periodontitis; Thyme honey; anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• Clinical attachment loss (CAL)

  With a periodontal probe, PD and CAL will be measured on six locations of the teeth (mesio-buccal/facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal).

  6 weeks

Secondary Outcomes (1)

• Bleeding on probing

  6 weeks

Study Arms (2)

Thyme honey

EXPERIMENTAL

The experimental group will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm. Thyme honey will be delivered to the sites until overflows using a syringe with plastic catheter of cannula 20 g (B Braun) attached to it. Patients will be reviewed at 6 weeks to re-evaluate the clinical periodontal parameters (Ibrahim et al., 2021).

Other: Thyme honey

Saline

PLACEBO COMPARATOR

The control group will receive scaling and root debridement with normal saline irrigation on sites with PPD ≥ 5 mm.

Other: Thyme honey

Interventions

Thyme honey OTHER

Thyme honey will be delivered to the sites until overflows using a syringe with plastic catheter of cannula 20 g (B Braun) attached to it. Patients will be reviewed at 6 weeks to re-evaluate the clinical periodontal parameters

Saline; Thyme honey

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Both genders, aged above 18 years.
• All patients must have a periodontal disease.
• Patients must be able to make reliable decision or communications.

You may not qualify if:

• \- Smoking, Alcohol.
• Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.

Sponsors & Collaborators

• British University In Egypt: lead

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical outcome assessor (A.A) will not be aware of which treatment will be being administered, thus yielding a single-blind controlled study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor anf Head of department

Model Details: The experimental group will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm. Thyme honey will be delivered to the sites until overflows using a syringe with plastic catheter of cannula 20 g (B Braun) attached to it. Patients will be reviewed at 6 weeks to re-evaluate the clinical periodontal parameters. The control group will receive scaling and root debridement with normal saline irrigation on sites with PPD ≥ 5 mm.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: January 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: February 20, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01