The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing

Gingival Bleeding Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02939092
• Other study ID #: CairoE
• Status: Not yet recruiting
• Phase: N/A
• First received: October 11, 2016
• Last updated: January 23, 2018
• Start date: January 2018
• Est. completion date: February 2018

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: Heba M Fouad, Bachelor
• Phone: 01001798183
• Email: heba.fouad[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Bleeding
• Gingival Hemorrhage
• Hemorrhage

Intervention

Drug:
• Pomegranates peel extract
Pomegranate is antimicrobial
• Chlorhexidine
Chlorhexidine mouthwash is antiplaque agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (6)

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. Epub 2002 Oct 23. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on brushing, Measurement: asking patient , Unit: Binary		2 weeks
Secondary	Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL		2 weeks

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