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Completed

NCT Number: NCT05631600

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

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.

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Key information

Conditions

Periodontal Diseases Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Bone Loss Periodontal Pocket Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

School of Dental Medicine

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

Primary outcomes

  1. Periodontal pocket depth

    Time frame: Baseline; 12 months

    Evaluation of changes of periodontal pocket depth

  2. Clinical attachment level

    Time frame: Baseline: 12 months

    Evaluation of changes in terms of clinical attachment gain

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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