Chronic PeriodontitisPROPOLISNCT01943877
Propolis In The Treatment Of Periodontitis
A study testing scaling root planing and Propolis in people with Chronic Periodontitis, run by Rajarajeswari Dental College & Hospital at 1 site in India.
Trial summary
This study was conducted to evaluate by clinical and microbiological parameters the effect of locally delivered propolis as an adjunct to scaling and root planing in the treatment of chronic periodontitis. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- scaling root planing and Propolis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2012to Oct 2013
- Phase
- Interventional
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general health
- chronic periodontitis
- minimum of 20 natural teeth with at least one pocket per quadrant
- probing depth (PD) between 5 and 8 mm.
Who cannot join
- subgingival instrumentation within 3 months
- antibiotic therapy within 3 months prior to the start of the study;
- smokers
- pregnant or nursing women
- intolerance or allergy to honey products
Trial locations and contacts
1 site in 1 country.
India1 site
Rajarajeswari Dental College and Hospital
Bangalore, Karnataka, 560060
About this study
Official title: Propolis In The Treatment Of Chronic Periodontitis - A Clinicomicrobiologic Study
This study was conducted to evaluate by clinical and microbiological parameters the effect of locally delivered propolis as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
Read the detailed description
Materials and Methods: 20 subjects diagnosed with chronic periodontitis were recruited to participate in split-mouth design and provided informed consent. Subgingival plaque sampling and clinical recording at baseline, 15 days and 1 month was performed. The patients received scaling and root planing, followed by Propolis administration subgingivally in the test sites. Significant differences between test and control were evaluated using the Mann-Whitney U test and Wilcoxon rank test.
- Conditions
- Chronic Periodontitis
- Being tested
- scaling root planing, Propolis
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling root planingProcedure or surgery
scaling root planing
PropolisDrug
experimental
| Study group | Role | What they receive |
|---|---|---|
| Propolis | Experimental | Not described Receives: Procedure: scaling root planing; Drug: Propolis |
| scaling and root planing | Sham comparator | Not described Receives: Procedure: scaling root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the probing pocket depth and clinical attachment level
Measured: three time points of baseline,2 weeks, 4 weeks
Secondary outcomes (1)
change in gingival index and microbiological changes
Measured: three time points baseline, 2 weeks, 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2013
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajarajeswari Dental College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NEHAL N SANGHANI, mds, Rajarajeswari Dental College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943877
- Sponsor's protocol ID
- 971987
- Acronym
- PROPOLIS
- Status last verified
- Sep 2013
- First submitted
- 2 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propolis In The Treatment Of Chronic Periodontitis - A Clinicomicrobiologic Study
- ClinicalTrials.gov ID
- NCT01943877
- Acronym / sponsor ID
- PROPOLIS / 971987
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rajarajeswari Dental College & HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (estimated)
- First posted
- 17 Sep 2013 (estimated)
- 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.
This study was conducted to evaluate by clinical and microbiological parameters the effect of locally delivered propolis as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
Detailed description
Materials and Methods: 20 subjects diagnosed with chronic periodontitis were recruited to participate in split-mouth design and provided informed consent. Subgingival plaque sampling and clinical recording at baseline, 15 days and 1 month was performed. The patients received scaling and root planing, followed by Propolis administration subgingivally in the test sites. Significant differences between test and control were evaluated using the Mann-Whitney U test and Wilcoxon rank test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis | Experimental | Procedure: scaling root planing, Drug: Propolis |
| scaling and root planing | Sham comparator | Procedure: scaling root planing |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- good general health
- chronic periodontitis
- minimum of 20 natural teeth with at least one pocket per quadrant
- probing depth (PD) between 5 and 8 mm.
Key exclusion criteria (5 listed)
- subgingival instrumentation within 3 months
- antibiotic therapy within 3 months prior to the start of the study;
- smokers
- pregnant or nursing women
- intolerance or allergy to honey products
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 |
|---|---|---|
| scaling root planingscaling root planing | Procedure or surgery | Propolis, scaling and root planing |
| Propolisexperimental | Drug | Propolis |
Primary outcome
Change in the probing pocket depth and clinical attachment level
Time frame: three time points of baseline,2 weeks, 4 weeks
1 secondary outcome
change in gingival index and microbiological changes
Time frame: three time points baseline, 2 weeks, 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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 study testing scaling root planing and Propolis in people with Chronic Periodontitis, run by Rajarajeswari Dental College & Hospital at 1 site in India.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Sep 2013. 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Change in the probing pocket depth and clinical attachment level (time frame: three time points of baseline,2 weeks, 4 weeks). 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 17 Sep 2013; AzTrials last refreshed its copy on 7 Nov 2026.