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

Sponsor

University of Zagreb (Other)

Overall Status

Completed

CT.gov ID

NCT05631600

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases Periodontal Pocket Periodontal Bone Loss Periodontal Attachment Loss	Biological: Manuka honey	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Split-mouth studySplit-mouth study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 11, 2017

Actual Primary Completion Date :

Sep 11, 2018

Actual Study Completion Date :

Sep 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: 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.

Arm

Intervention/Treatment

Experimental: 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.

Biological: 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.

Outcome Measures

Primary Outcome Measures

Periodontal pocket depth [Baseline; 12 months]
Evaluation of changes of periodontal pocket depth
Clinical attachment level [Baseline: 12 months]
Evaluation of changes in terms of clinical attachment gain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.).