Periodontal DiseasesPhase 2/3NCT05631600
Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study
A Phase 2/3 study testing Manuka honey in people with Periodontal Diseases and Periodontal Pocket, run by University of Zagreb at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Pocket, Periodontal Bone Loss
- What is being tested?
- Manuka honey
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCroatia
- Study dates
- 11 Sep 2017to 11 Sep 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this 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:
Read more
- 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
- Being tested
- Manuka honey
- Keywords
- Periodontitis, Manuka honey, Periodontal pocket depth
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket, Alveolar Bone Loss, Periodontal Attachment Loss, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka honeyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Manuka honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth
Evaluation of changes of periodontal pocket depth
Measured: Baseline; 12 months
Clinical attachment level
Evaluation of changes in terms of clinical attachment gain
Measured: Baseline: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start11 Sep 2017
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Split-mouth study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darko Bozic, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631600
- Sponsor's protocol ID
- 05-PA-30-IX-9/2019
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study
- ClinicalTrials.gov ID
- NCT05631600
- Acronym / sponsor ID
- 05-PA-30-IX-9/2019
- Conditions
- Periodontal Diseases, Periodontal Pocket, Periodontal Bone Loss, Periodontal Attachment Loss
- Keywords
- Periodontitis, Manuka honey, Periodontal pocket depth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Split-mouth study
| Arm | Type | Receives |
|---|---|---|
| Manuka honey | Experimental | Biological: Manuka honeyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manuka honeyThe 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. | Biological | Manuka honey |
Primary outcome
Periodontal pocket depth
Time frame: Baseline; 12 months
Evaluation of changes of periodontal pocket depth
Clinical attachment level
Time frame: Baseline: 12 months
Evaluation of changes in terms of clinical attachment gain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Manuka honey in people with Periodontal Diseases and Periodontal Pocket, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal pocket depth (time frame: Baseline; 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.