Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study

NCT ID: NCT05631600

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2018-09-11

Brief Summary

The goal of this split-mouth clinical trial is to evaluate the effects of Manuka honey applied into periodontal pockets after initial periodontal therapy (NSPT) in the treatment of stage 3 periodontitis.

The main question it aims to answer is:

• does the adjunct of Manuka honey improve the outcome of the non-surgical periodontal treatment.

The intervention in this study was conducted in a split-mouth design, meaning that after completing the NSPT for each subject, Manuka honey was administered as an adjunct to the periodontal treatment in two randomly selected quadrants of the oral cavity around the teeth with a specially designed cannula.

This was followed by oral hygiene instructions and training. The home-performed oral hygiene procedures were focused on interdental cleaning using dental floss and toothbrushing with regular fluoride-containing toothpaste. The subjects were also instructed not to use any form of oral antiseptic (e.g., chlorhexidine) or antibiotic during the follow-up period.

Conditions

Periodontal Diseases; Periodontal Pocket; Periodontal Bone Loss; Periodontal Attachment Loss

Keywords

Periodontitis; Manuka honey; Periodontal pocket depth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Manuka honey

The intervention in this study was conducted in a split-mouth design, meaning that after completing the NSPT for each subject, Manuka honey was administered as an adjunct to the periodontal treatment in two randomly selected quadrants of the oral cavity around the teeth with a specially designed cannula. The cannula reached the bottom of the periodontal pocket and moved circumferentially around the tooth at 6 sites, and Manuka honey was extruded until the excess of the material was observed in the sulcus.

Group Type: EXPERIMENTAL

Manuka honey

Intervention Type: BIOLOGICAL

The honey was applied with special designed cannula. The dosage is not exactly define so we inject the amount of honey until until the excess of the material was observed in the sulcus.

Interventions

Manuka honey

The honey was applied with special designed cannula. The dosage is not exactly define so we inject the amount of honey until until the excess of the material was observed in the sulcus.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients of both genders with good systemic health;
• Non-smokers;
• Presence of at least 20 teeth;
• Untreated moderate to advanced generalized chronic periodontitis according to the 1999 Classification 199 , i.e., generalized stage III periodontitis according to the 2007 Classification

Exclusion Criteria

• Pregnant and nursing women;
• Antibiotics prescribed for dental or non-dental diseases 6 months before the start of the research;
• Systemic diseases or the use of drugs known to affect periodontal tissues, bleeding parameters;
• Acute oral or periodontal inflammation or infection (pericoronitis, necrotizing periodontal diseases, etc.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Darko Bozic

Associate professor of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Dental Medicine

Zagreb, , Croatia

Countries

Croatia

Other Identifiers

05-PA-30-IX-9/2019

Identifier Type: -

Identifier Source: org_study_id