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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02939092

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Bleeding	Drug: Pomegranates peel extract Drug: Chlorhexidine	N/A

Detailed Description

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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pomegranate peel extract Pomegranate is antimicrobial, anti inflammatory and antioxidant	Drug: Pomegranates peel extract Pomegranate is antimicrobial
Active Comparator: Chlorhexidine Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis	Drug: Chlorhexidine Chlorhexidine mouthwash is antiplaque agent

Arm

Intervention/Treatment

Experimental: Pomegranate peel extract

Pomegranate is antimicrobial, anti inflammatory and antioxidant

Drug: Pomegranates peel extract

Pomegranate is antimicrobial

Active Comparator: Chlorhexidine

Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis

Drug: Chlorhexidine

Chlorhexidine mouthwash is antiplaque agent

Outcome Measures

Primary Outcome Measures

Bleeding on brushing, Measurement: asking patient , Unit: Binary [2 weeks]

Secondary Outcome Measures

Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Salah El Behery, Professor, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Heba Moahmed Fouad, Principle investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT02939092

Other Study ID Numbers:

CairoE

First Posted:

Oct 19, 2016

Last Update Posted:

Jan 24, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Heba Moahmed Fouad, Principle investigator, Cairo University

Gingival Bleeding on probing

Additional relevant MeSH terms:

Gingival Hemorrhage

Hemorrhage

Chlorhexidine

Study Results

No Results Posted as of Jan 24, 2018