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Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2017/09/009684
Date of registration:	08-09-2017
Prospective Registration:	No
Primary sponsor:	Schulke Mayr Asia Sdn Bhd
Public title:	Effects of Octenidol mouthwash with professional teeth cleaning on gum and oral health
Scientific title:	Efficacy of OctenidolÂ® mouthwash as an adjunct to non-surgical periodontal therapy in chronic periodontitis patients: A Randomized Control Clinical Trial
Date of first enrolment:	04-04-2016
Target sample size:	24
Recruitment status:	Not Applicable
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17961
Study type:	Interventional
Study design:	Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Random Number Table Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
Phase:	Phase 4

Countries of recruitment
Malaysia

Contacts

Name:	Avita Rath
Address:	Segi University NO 9 JALAN TEKNOLOGI Taman Sains Selangor Kota Damansara PJU5 47810 Coimbatore, TAMIL NADU Other
Telephone:	60109677452
Email:	avitashanti@segi.edu.my
Affiliation:	SEGi University

Name:	Avita Rath
Address:	Segi University NO 9 JALAN TEKNOLOGI Taman Sains Selangor Kota Damansara PJU5 47810 Coimbatore, TAMIL NADU Other
Telephone:	60109677452
Email:	avitashanti@segi.edu.my
Affiliation:	SEGi University

Key inclusion & exclusion criteria

Inclusion criteria: systemically healthy patients with at least 20 natural teeth or more, not wearing dentures or any orthodontic appliances
Exclusion criteria: patients with allergy, history of medical or systemic illness, alcohol abuse, and currently using antimicrobial mouthwash prior 60 days

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Chronic periodontitis

Intervention(s)

Intervention1: Octenidol Mouthwash: 0.1% Octenidine dihydrochloride
10 ml BID for 21 days oral rinsing
Control Intervention1: control: mouthrinse with same formulation but no active ingredient( octenidine dihydrocholoride)
10 ml BID for 21 days oral rinsing

Primary Outcome(s)

reduction in plaque and gingival inflammationTimepoint: every week scores were taken for 3 weeks in this 21 day trial

Secondary Outcome(s)

taste alteration if any

extrinsic stains due to use of the mouthwashesTimepoint: scores for patients perception of the mouthwash was taken at the end of 3rd week

Secondary ID(s)

NIL

Source(s) of Monetary Support

SEGi University No 9 Jalan Teknologi PJU5 Taman Sains Selangor 47810 Kota Damansara Malaysia

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 30/03/2016
Contact:

Ethic Commitee, SEGi University

Results

Results available:
Date Posted:
Date Completed:
URL:

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