NCT02939092

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

October 11, 2016

Last Update Submit

January 23, 2018

Conditions

Gingival Bleeding

Keywords

Gingival Bleeding on probing

Outcome Measures

Primary Outcomes (1)

  • Bleeding on brushing, Measurement: asking patient , Unit: Binary

    2 weeks

Secondary Outcomes (1)

  • Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL

    2 weeks

Study Arms (2)

Pomegranate peel extract

EXPERIMENTAL

Pomegranate is antimicrobial, anti inflammatory and antioxidant

Drug: Pomegranates peel extract

Chlorhexidine

ACTIVE COMPARATOR

Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis

Drug: Chlorhexidine

Interventions

Pomegranates peel extractDRUG

Pomegranate is antimicrobial

Pomegranate peel extract
ChlorhexidineDRUG

Chlorhexidine mouthwash is antiplaque agent

Chlorhexidine

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children aged 12-15 years old.
  • Cooperative children.
  • Both genders.
  • Medically free.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 23762148BACKGROUND

  • Umar 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.

    PMID: 26955605BACKGROUND

  • Tulsani 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.

    PMID: 25728105BACKGROUND

  • Ajdic 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.

    PMID: 12397186BACKGROUND

  • Filoche 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.

    PMID: 15943766BACKGROUND

  • Zarfeshany 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.

    PMID: 24800189BACKGROUND

Related Links

MeSH Terms

Conditions

Gingival Hemorrhage

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Oral HemorrhageMouth DiseasesStomatognathic DiseasesGingival DiseasesPeriodontal DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Salah El Behery, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Heba M Fouad, Bachelor

CONTACT

01001798183heba.fouad@dentistry.cu.edu.eg

Manal El shiekh, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 19, 2016

Study Start

January 1, 2018

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

January 24, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share