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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631600
• Other study ID #: 05-PA-30-IX-9/2019
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 11, 2017
• Est. completion date: September 11, 2018

Study information

• Verified date: November 2022
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Attachment Loss
• Periodontal Bone Loss
• Periodontal Diseases
• Periodontal Pocket

Intervention

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.

Locations

Country	Name	City	State
Croatia	School of Dental Medicine	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal pocket depth	Evaluation of changes of periodontal pocket depth	Baseline; 12 months
Primary	Clinical attachment level	Evaluation of changes in terms of clinical attachment gain	Baseline: 12 months