GingivitisNCT02949583
Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children
A study testing Punica granatum Linn. and chlorhexidine in people with Gingivitis, run by Universidade Estadual da Paraiba at 1 site in Brazil.
Trial summary
The mechanical control of supragingival biofilm is accepted as one of the most important measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental surfaces biofilm-free is not an easy task. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Punica granatum Linn. and chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to May 2012
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group: 09-12 years old
- Presence of at least 20 teeth
- Simplified Oral Hygiene Index (S-OHI)≥ 1,6
Who cannot join
- Use of orthodontic appliance
- Recent (in the past 2 months)use of antibiotics and mouthwashes
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual Da Paraiba
Campina Grande, Paraíba, 58.429-500
About this study
Official title: Clinical Effectiveness and Microbiological Evaluation of a Mouthwash of Pomegranate (Punica Granatum Linn.) in School Children
The mechanical control of supragingival biofilm is accepted as one of the most important measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients that prevent and control both supragingival biofilm and gingivitis, specially when used adjunctively to mechanical oral hygiene regimens.
Read the detailed description
In vitro and clinical researches using Punica granatum Linn shows antimicrobial and antiadherent activity against dental biofilm microorganisms. The purpose of this study was to evaluate the clinical effectiveness of a mouthwash of Punica granatum Linn. against biofilm and gingival inflammation in school children
- Conditions
- Gingivitis
- Being tested
- Punica granatum Linn., chlorhexidine
- Keywords
- DENTAL PLAQUE, MEDICINAL PLANTS, GINGIVITIS
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punica granatum Linn.Drug
Also called Pomegranate
Mouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days
chlorhexidineDrug
Also called Periogard
standard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Punica granatum Linn. | Experimental | The childrens used the mouthwash contain pomegranate 6,25% twice daily for 14 days. Receives: Drug: Punica granatum Linn. |
| chlorhexidine | Active comparator | The childrens used the mouthwash contain chlorhexidine 0.12% twice daily for 14 days. Receives: Drug: chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Gingival Index scores.
On day 0, we measured the Plaque Index (PI) (Silness; Löe, 1964) at baseline, on the seventh day and on the fourteenth day.
Measured: Baseline, Seventh Day and Fourteeth day (14 days)
Difference in the Gingival Bleeding Index scores.
On day 0, we measured the Bleeding on Probing Index (BPI) (Ainamo; Bay, 1975) at baseline, on the seventh day and on the fourteenth day.
Measured: Baseline, Seventh Day andFourteeth day (14 days)
Difference in the Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study.
At baseline, we collected non-stimulated saliva samples into a sterile container for counting of oral streptococci in the laboratory. And on the fourteenth day, we carried out the second saliva collection and measured the clinical indices used.
Measured: Baseline and Fourteeth day (14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual da Paraiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DANÚBIA ROBERTA DE MEDEIROS NÓBREGA, Universidade Estadual da Paraiba
- Investigators
- DANÚBIA RM NÓBREGA, Mastering, Principal investigator, Universidade Estadual da Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949583
- Sponsor's protocol ID
- Effectiveness of Pomegranate
- Status last verified
- Oct 2016
- First submitted
- 20 May 2014
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Menezes SM, Cordeiro LN, Viana GS. Punica granatum (pomegranate) extract is active against dental plaque. J Herb Pharmacother. 2006;6(2):79-92.
PubMed 17182487Bhadbhade SJ, Acharya AB, Rodrigues SV, Thakur SL. The antiplaque efficacy of pomegranate mouthrinse. Quintessence Int. 2011 Jan;42(1):29-36.
PubMed 21206931DiSilvestro RA, DiSilvestro DJ, DiSilvestro DJ. Pomegranate extract mouth rinsing effects on saliva measures relevant to gingivitis risk. Phytother Res. 2009 Aug;23(8):1123-7. doi: 10.1002/ptr.2759.
PubMed 19170139Vasconcelos LC, Sampaio FC, Sampaio MC, Pereira Mdo S, Higino JS, Peixoto MH. Minimum inhibitory concentration of adherence of Punica granatum Linn (pomegranate) gel against S. mutans, S. mitis and C. albicans. Braz Dent J. 2006;17(3):223-7. doi: 10.1590/s0103-64402006000300009.
PubMed 17262129
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Microbiological Evaluation of a Mouthwash of Pomegranate (Punica Granatum Linn.) in School Children
- ClinicalTrials.gov ID
- NCT02949583
- Acronym / sponsor ID
- Effectiveness of Pomegranate
- Conditions
- Gingivitis
- Keywords
- DENTAL PLAQUE, MEDICINAL PLANTS, GINGIVITIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Estadual da ParaibaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Oct 2016 (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.
The mechanical control of supragingival biofilm is accepted as one of the most important measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients that prevent and control both supragingival biofilm and gingivitis, specially when used adjunctively to mechanical oral hygiene regimens.
Detailed description
In vitro and clinical researches using Punica granatum Linn shows antimicrobial and antiadherent activity against dental biofilm microorganisms. The purpose of this study was to evaluate the clinical effectiveness of a mouthwash of Punica granatum Linn. against biofilm and gingival inflammation in school children
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Punica granatum Linn. | Experimental | Drug: Punica granatum Linn.The childrens used the mouthwash contain pomegranate 6,25% twice daily for 14 days. |
| chlorhexidine | Active comparator | Drug: chlorhexidineThe childrens used the mouthwash contain chlorhexidine 0.12% twice daily for 14 days. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age group: 09-12 years old
- Presence of at least 20 teeth
- Simplified Oral Hygiene Index (S-OHI)≥ 1,6
Key exclusion criteria (2 listed)
- Use of orthodontic appliance
- Recent (in the past 2 months)use of antibiotics and mouthwashes
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 |
|---|---|---|
| Punica granatum Linn.Also: PomegranateMouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days | Drug | Punica granatum Linn. |
| chlorhexidineAlso: Periogardstandard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days | Drug | chlorhexidine |
Primary outcome
Difference in the Gingival Index scores.
Time frame: Baseline, Seventh Day and Fourteeth day (14 days)
On day 0, we measured the Plaque Index (PI) (Silness; Löe, 1964) at baseline, on the seventh day and on the fourteenth day.
Difference in the Gingival Bleeding Index scores.
Time frame: Baseline, Seventh Day andFourteeth day (14 days)
On day 0, we measured the Bleeding on Probing Index (BPI) (Ainamo; Bay, 1975) at baseline, on the seventh day and on the fourteenth day.
Difference in the Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study.
Time frame: Baseline and Fourteeth day (14 days)
At baseline, we collected non-stimulated saliva samples into a sterile container for counting of oral streptococci in the laboratory. And on the fourteenth day, we carried out the second saliva collection and measured the clinical indices used.
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 31 Oct 2016.
- Background: PubMed 17182487Menezes SM, Cordeiro LN, Viana GS. Punica granatum (pomegranate) extract is active against dental plaque. J Herb Pharmacother. 2006;6(2):79-92.
- Background: PubMed 21206931Bhadbhade SJ, Acharya AB, Rodrigues SV, Thakur SL. The antiplaque efficacy of pomegranate mouthrinse. Quintessence Int. 2011 Jan;42(1):29-36.
- Background: PubMed 19170139DiSilvestro RA, DiSilvestro DJ, DiSilvestro DJ. Pomegranate extract mouth rinsing effects on saliva measures relevant to gingivitis risk. Phytother Res. 2009 Aug;23(8):1123-7. doi: 10.1002/ptr.2759.
- Background: PubMed 17262129Vasconcelos LC, Sampaio FC, Sampaio MC, Pereira Mdo S, Higino JS, Peixoto MH. Minimum inhibitory concentration of adherence of Punica granatum Linn (pomegranate) gel against S. mutans, S. mitis and C. albicans. Braz Dent J. 2006;17(3):223-7. doi: 10.1590/s0103-64402006000300009.
- 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.
DANÚBIA RM NÓBREGA, Mastering principal investigator
Universidade Estadual da Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punica granatum Linn. and chlorhexidine in people with Gingivitis, run by Universidade Estadual da Paraiba at 1 site in Brazil.
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 3 inclusion and 2 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 31 Oct 2016. 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 Brazil. 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.
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?
Difference in the Gingival Index scores. (time frame: Baseline, Seventh Day and Fourteeth day (14 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949583, which also lists 4 linked publications.
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 31 Oct 2016.