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

NCT05631600 | Completed Phase 2

• 1 other identifier: 05-PA-30-IX-9/2019
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Periodontal pocket depth

  Evaluation of changes of periodontal pocket depth

  Baseline; 12 months

• Clinical attachment level

  Evaluation of changes in terms of clinical attachment gain

  Baseline: 12 months

Study Arms (1)

Manuka honey

EXPERIMENTAL

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

Interventions

Manuka honey 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.

Manuka honey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of Dental Medicine

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket; Alveolar Bone Loss; Periodontal Attachment Loss; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Periodontology

Model Details: Split-mouth study

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 30, 2022
• Study Start: September 11, 2017
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)