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

Primary Purpose

Periodontal Diseases, Periodontal Pocket, Periodontal Bone Loss

Status
Completed
Phase
Phase 2
Locations
Croatia
Study Type
Interventional
Intervention
Manuka honey
Sponsored by
University of Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontitis, Manuka honey, Periodontal pocket depth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.).

Sites / Locations

  • School of Dental Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Manuka honey

Arm Description

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.

Outcomes

Primary Outcome Measures

Periodontal pocket depth
Evaluation of changes of periodontal pocket depth
Clinical attachment level
Evaluation of changes in terms of clinical attachment gain

Secondary Outcome Measures

Full Information

First Posted
October 26, 2022
Last Updated
November 19, 2022
Sponsor
University of Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT05631600
Brief Title
Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study
Official Title
Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periodontal Pocket, Periodontal Bone Loss, Periodontal Attachment Loss
Keywords
Periodontitis, Manuka honey, Periodontal pocket depth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Split-mouth study
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manuka honey
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Manuka honey
Intervention Description
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 Outcome Measure Information:
Title
Periodontal pocket depth
Description
Evaluation of changes of periodontal pocket depth
Time Frame
Baseline; 12 months
Title
Clinical attachment level
Description
Evaluation of changes in terms of clinical attachment gain
Time Frame
Baseline: 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.).
Facility Information:
Facility Name
School of Dental Medicine
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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