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

Phase 2

Completed

• Conditions: Periodontal Diseases; Periodontal Bone Loss; Periodontal Pocket; Periodontal Attachment Loss
• Interventions: Biological: Manuka honey

• Registration Number: NCT05631600
• Lead Sponsor: University of Zagreb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-11
• Primary Completion: 2018-09-11
• Study Completion: 2018-09-11
• Study First Submitted: 2022-10-26
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-19
• Last Update Submitted: 2022-11-19
• Study First Posted: 2022-11-30
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Manuka honey	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.

Primary Outcome Measures

Name	Time	Method
Clinical attachment level	Baseline: 12 months	Evaluation of changes in terms of clinical attachment gain
Periodontal pocket depth	Baseline; 12 months	Evaluation of changes of periodontal pocket depth

Trial Locations

Locations (1)

School of Dental Medicine; 🇭🇷 Zagreb, Croatia