Clinical trial NCT02939092: The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Bleeding
Keywords: Gingival Bleeding on probing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Bleeding on brushing, Measurement: asking patient , Unit: Binary
timeFrame: 2 weeks
Secondary outcomes:
measure: Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Salah El Behery, Professor
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.