Gingival BleedingNCT02939092
The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing
A study testing Pomegranates peel extract and Chlorhexidine in people with Gingival Bleeding, run by Cairo University.
Trial summary
To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Bleeding
- What is being tested?
- Pomegranates peel extract and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Feb 2018
- 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 12-15 years old.
- Cooperative children.
- Both genders.
- Medically free.
Who cannot join
- Children undergoing orthodontic treatment.
- Children using any other oral hygiene aid other than routine teeth brushing.
- Children with known history of allergy to any mouth rinse or drug.
- Parents unable to give informed consent.
Trial locations and contacts
No sites are listed yet.
Manal El shiekh, Lecturer contact
About this study
Official title: The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing Among a Group of Egyptian Children With Full Permanent Dentition, Randomized Controlled Trial
To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.
Read the detailed description
To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.
PICO:
Population (P): Children with full permanent dentition. Intervention (I): Pomegranates peel extract. Comparator (C): Chlorhexidine.
Outcome(O):
Primary outcome: Bleeding on brushing, criteria:Asking patient, unit:Binary. Secondary outcome:Counting streptococcus mutans, criteria: Agar plate, unit: CFUs/mL
- Conditions
- Gingival Bleeding
- Being tested
- Pomegranates peel extract, Chlorhexidine
- Keywords
- Gingival Bleeding on probing
- Medical subject headings
- Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranates peel extractDrug
Pomegranate is antimicrobial
ChlorhexidineDrug
Chlorhexidine mouthwash is antiplaque agent
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate peel extract | Experimental | Pomegranate is antimicrobial, anti inflammatory and antioxidant Receives: Drug: Pomegranates peel extract |
| Chlorhexidine | Active comparator | Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on brushing, Measurement: asking patient , Unit: Binary
Measured: 2 weeks
Secondary outcomes (1)
Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJan 2018 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gingival BleedingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Moahmed Fouad, Cairo University
- Investigators
- Salah El Behery, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939092
- Sponsor's protocol ID
- CairoE
- Status last verified
- Jan 2018
- First submitted
- 11 Oct 2016
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howell AB, D'Souza DH. The pomegranate: effects on bacteria and viruses that influence human health. Evid Based Complement Alternat Med. 2013;2013:606212. doi: 10.1155/2013/606212. Epub 2013 May 20.
PubMed 23762148Umar D, Dilshad B, Farhan M, Ali A, Baroudi K. The effect of pomegranate mouthrinse on Streptococcus mutans count and salivary pH: An in vivo study. J Adv Pharm Technol Res. 2016 Jan-Mar;7(1):13-6. doi: 10.4103/2231-4040.173266.
PubMed 26955605Tulsani SG, Chikkanarasaiah N, Siddaiah SB, Krishnamurthy NH. The effect of Propolis and Xylitol chewing gums on salivary Streptococcus mutans count: a clinical trial. Indian J Dent Res. 2014 Nov-Dec;25(6):737-41. doi: 10.4103/0970-9290.152182.
PubMed 25728105Ajdic D, McShan WM, McLaughlin RE, Savic G, Chang J, Carson MB, Primeaux C, Tian R, Kenton S, Jia H, Lin S, Qian Y, Li S, Zhu H, Najar F, Lai H, White J, Roe BA, Ferretti JJ. Genome sequence of Streptococcus mutans UA159, a cariogenic dental pathogen. Proc Natl Acad Sci U S A. 2002 Oct 29;99(22):14434-9. doi: 10.1073/pnas.172501299. Epub 2002 Oct 23.
PubMed 12397186Filoche SK, Soma K, Sissons CH. Antimicrobial effects of essential oils in combination with chlorhexidine digluconate. Oral Microbiol Immunol. 2005 Aug;20(4):221-5. doi: 10.1111/j.1399-302X.2005.00216.x.
PubMed 15943766Zarfeshany A, Asgary S, Javanmard SH. Potent health effects of pomegranate. Adv Biomed Res. 2014 Mar 25;3:100. doi: 10.4103/2277-9175.129371. eCollection 2014.
PubMed 24800189
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing Among a Group of Egyptian Children With Full Permanent Dentition, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02939092
- Acronym / sponsor ID
- CairoE
- Conditions
- Gingival Bleeding
- Keywords
- Gingival Bleeding on probing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 19 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.
To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.
Detailed description
To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.
PICO:
Population (P): Children with full permanent dentition. Intervention (I): Pomegranates peel extract. Comparator (C): Chlorhexidine.
Outcome(O):
Primary outcome: Bleeding on brushing, criteria:Asking patient, unit:Binary. Secondary outcome:Counting streptococcus mutans, criteria: Agar plate, unit: CFUs/mL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate peel extract | Experimental | Drug: Pomegranates peel extractPomegranate is antimicrobial, anti inflammatory and antioxidant |
| Chlorhexidine | Active comparator | Drug: ChlorhexidineChlorhexidine mouthwash is antiplaque treatment and effective against gingivitis |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children aged 12-15 years old.
- Cooperative children.
- Both genders.
- Medically free.
Key exclusion criteria (4 listed)
- Children undergoing orthodontic treatment.
- Children using any other oral hygiene aid other than routine teeth brushing.
- Children with known history of allergy to any mouth rinse or drug.
- Parents unable to give informed consent.
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 |
|---|---|---|
| Pomegranates peel extractPomegranate is antimicrobial | Drug | Pomegranate peel extract |
| ChlorhexidineChlorhexidine mouthwash is antiplaque agent | Drug | Chlorhexidine |
Primary outcome
Bleeding on brushing, Measurement: asking patient , Unit: Binary
Time frame: 2 weeks
1 secondary outcome
Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Background: PubMed 23762148Howell AB, D'Souza DH. The pomegranate: effects on bacteria and viruses that influence human health. Evid Based Complement Alternat Med. 2013;2013:606212. doi: 10.1155/2013/606212. Epub 2013 May 20.
- Background: PubMed 26955605Umar D, Dilshad B, Farhan M, Ali A, Baroudi K. The effect of pomegranate mouthrinse on Streptococcus mutans count and salivary pH: An in vivo study. J Adv Pharm Technol Res. 2016 Jan-Mar;7(1):13-6. doi: 10.4103/2231-4040.173266.
- Background: PubMed 25728105Tulsani SG, Chikkanarasaiah N, Siddaiah SB, Krishnamurthy NH. The effect of Propolis and Xylitol chewing gums on salivary Streptococcus mutans count: a clinical trial. Indian J Dent Res. 2014 Nov-Dec;25(6):737-41. doi: 10.4103/0970-9290.152182.
- Background: PubMed 12397186Ajdic D, McShan WM, McLaughlin RE, Savic G, Chang J, Carson MB, Primeaux C, Tian R, Kenton S, Jia H, Lin S, Qian Y, Li S, Zhu H, Najar F, Lai H, White J, Roe BA, Ferretti JJ. Genome sequence of Streptococcus mutans UA159, a cariogenic dental pathogen. Proc Natl Acad Sci U S A. 2002 Oct 29;99(22):14434-9. doi: 10.1073/pnas.172501299. Epub 2002 Oct 23.
- Background: PubMed 15943766Filoche SK, Soma K, Sissons CH. Antimicrobial effects of essential oils in combination with chlorhexidine digluconate. Oral Microbiol Immunol. 2005 Aug;20(4):221-5. doi: 10.1111/j.1399-302X.2005.00216.x.
- Background: PubMed 24800189Zarfeshany A, Asgary S, Javanmard SH. Potent health effects of pomegranate. Adv Biomed Res. 2014 Mar 25;3:100. doi: 10.4103/2277-9175.129371. eCollection 2014.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Manal El shiekh, Lecturer contact
Salah El Behery, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranates peel extract and Chlorhexidine in people with Gingival Bleeding, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba M Fouad, Bachelor (01001798183, heba.fouad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on brushing, Measurement: asking patient , Unit: Binary (time frame: 2 weeks). 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 NCT02939092, which also lists 6 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 24 Jan 2018.