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Register:	ISRCTN
Last refreshed on:	11 June 2018
Main ID:	ISRCTN66780304
Date of registration:	11/05/2018
Prospective Registration:	No
Primary sponsor:	Procter & Gamble
Public title:	The effect of an oral hygiene regimen on periodontal health
Scientific title:	Long-term use of combination oral hygiene on gingival and periodontal health: a pilot study
Date of first enrolment:	16/02/2014
Target sample size:	110
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN66780304
Study type:	Interventional
Study design:	Single-center randomized controlled examiner-blind two-treatment parallel study (Prevention)
Phase:

Countries of recruitment
Israel

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Avraham Zini
Address:	Department of Community Dentistry Faculty of Dental Medicine, Hadassah - Hebrew University Medical Center 91120 Jerusalem Israel
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 1. Give written informed consent and receive a copy of their consent
2. Be between the ages of 18 and 65
3. Be in good general health as determined by the Investigator/designee based on a review of the medical history/update for participation in the study
4. Possess a minimum of 16 natural teeth (excluding third molars) with facial and lingual scorable surfaces
5. Have at least 20 bleeding sites (sum of sites with a score of 1 or 2 on the GBI index)
6. Have at least: 3 eligible healthy sites (PPD <3 mm, no bleeding), 3 eligible gingivitis sites (PPD < 3 mm, bleeding), and 3 eligible periodontal sites (PPD 3-6 mm, bleeding)
7. Agree to delay any elective dentistry until study completion, including additional dental prophylaxes outside the study protocol
8. Agree to refrain from using any non-study oral hygiene products for the study duration (subject will be allowed to continue using floss but they will be instructed not to add/change any other oral hygiene products, including whitening products etc)
9. Agree not to participate in any other oral care clinical study for the duration of this study
10. Agree to return for their scheduled visits and follow study procedures
Exclusion criteria: 1. Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
2. Active treatment for periodontitis
3. Having a medical condition requiring antibiotic pre-medication prior to dental procedures
4. Fixed facial or lingual orthodontic appliances or removable partial dentures
5. Antibiotic or chlorhexidine use or anti-inflammatory medications within two weeks prior to Screening visit
6. Self-report nursing, pregnancy, or intent to become pregnant during the study
7. Dental prophylaxis within two months prior to the Screening visit
8. Any diseases or conditions that could be expected to interfere with the subject safely completing the study

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Oral concomitant periodontitis
Oral Health
Chronic periodontitis

Intervention(s)

Participants are stratified based on Screening mean Probing Pocket Depth, mean Gingival Bleeding Index, mean age, gender and tobacco use. Within strata, participants are randomly assigned equally to either the regimen group (antimicrobial paste, rinse, floss and an electrical toothbrush) or the control group (standard anti-cavity toothpaste and a regular manual toothbrush).

Participants of the regimen group are instructed to brush their teeth with the assigned electrical toothbrush and dentifrice for two minutes twice a day (morning and evening) following the manufacturer’s usage instructions and to floss the whole mouth once daily for the duration of the study. Participants rinse with water after brushing to remove remaining toothpaste and then rinse with 20ml of the mouth rinse for 30 seconds. Subjects used only the treatment products in place of normal oral hygiene products for the duration of the study.

Participants of the control group are instructed to brush their teeth with the assigned products twice daily (morning and evening) in their customary manner. Subjects are instructed to rinse with water after brushing. Participants use only the treatment products in place of normal oral hygiene products for the duration of the study (they are allowed to continue using floss but they are instructed not to add/change any other oral hygiene products).

Participants are requested to use their assigned products at home for the duration of the study (2 years).

Primary Outcome(s)

Measured at baseline, month 6, 12, 18 and 24:
1. Gingival inflammation, measured by Modified Gingival Index
2. Bleeding, measured by Gingival Bleeding Index
3. Periodontal measurements (Gingival Recession and Probing Pocket Depth)

Secondary Outcome(s)

No secondary outcome measures

Secondary ID(s)

Clinical Protocol 2013078

Source(s) of Monetary Support

Procter and Gamble

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Hadassah Medical Organization Helsinki Committee, 24/12/2013, IRB Approval #: 0482-13-HMO

Results

Results available:	Yes
Date Posted:
Date Completed:	11/02/2016
URL:

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