Thyme Honey Mouthwash in Management of Periodontitis in Renal Patients

NCT06129097 | Completed DMC

• 1 other identifier: 23-063
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

There is a known correlation between oral health and systemic disease. Particularly significant evidences associate periodontal bacteria and tooth loss to systemic disorders and specifically to cardiovascular disease, such as high BP. Furthermore, a correlation between periodontal disease and hypertension has been recently reported ESRD and the medications used by those patients create complications in a variety of systems and organs, which frequently worsens or causes new pathologies in the oral cavity, such as caries, periodontal disease, and different mucosal lesions. Therefore, the current trial was set up to first evaluate the effect of thyme honey oral rinse in ESRD patients with periodontitis using CAL as a primary objective, and to evaluate the clinical effectiveness of thyme honey oral rinse in ESRD patients with periodontitis on bleeding on probing (BOP) and plaque index, and salivary NO levels as secondary objectives.

Conditions

Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss; Periodontal Inflammation

Keywords

Thyme honey; Nitric oxide; Hemodialysis; Periodontitis

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 (3)

• Bleeding on probing

  6 weeks

• Plaque index

  6 weeks

• Salivary Nitric oxide levels

  6 weeks

Study Arms (2)

Thyme honey mouthwash

EXPERIMENTAL

* Thyme honey will be applied as oral rinse. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse.

Other: Thyme honey mouthwash

Saline mouthwash

PLACEBO COMPARATOR

Patients in the control arm followed the same protocol with normal saline rinses.

Other: Thyme honey mouthwash

Interventions

Thyme honey mouthwash OTHER

* Thyme honey will be applied as oral rinse. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse.

Saline mouthwash; Thyme honey mouthwash

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 be clinically diagnosed of ESRD undergoing hemodialysis.
• All patients must have a periodontal disease.
• Patients must be able to make reliable decision or communications.

You may not qualify if:

• \- Smoking, Alcohol.
• Patient with history of any serious illness as malignancy, who undergo kidney transplant.
• Patients with any autoimmune disease.
• Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
• Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British University in Egypt

Cairo, 3753450, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Dalia Ghalwash, Phd

  The British University in Egypt

  STUDY DIRECTOR

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: Lecturer Assistant

Model Details: Treatment protocol (for the intervention group): * Thyme honey will be applied as oral rinse. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse. The control group (placebo): Patients in the control arm followed the same protocol with normal saline rinses. All patients will receive a course of motivation, oral hygiene instructions (emphasizing proper tooth brushing technique, flossing, interdental brush, and mouthwash usage), scaling, polishing and root debridement with an ultrasonic scaler and Gracey curettes.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: January 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

EG (1)