Condition category
Oral Health
Date applied
13/12/2006
Date assigned
13/02/2007
Last edited
08/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Tickle

ORCID ID

Contact details

The University of Manchester
School of Dentistry
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

S&P TRIAL

Study hypothesis

Working hypotheses:
1. Adult patients of General Dental Practitioners (GDPs) who receive one visit scale and polishes at six monthly intervals will have less gingival bleeding around a set of index teeth compared to patients who receive one visit scale and polishes at 12- and 24-month intervals
2. Adult patients of GDPs who receive one-visit scale and polishes at six monthly intervals have less plaque around a set of index teeth compared with patients who receive one visit scale and polishes at 12- and 24-month intervals
3. Adult patients of GDPs who receive one-visit scale and polishes at six monthly intervals will have less calculus around a set of index teeth compared to patients who receive one visit scale and polishes at 12- and 24-month intervals
4. Adult patients of GDPs who receive one-visit scale and polishes at six monthly intervals report higher levels of oral cleanliness compared to patients who receive one visit scale and polishes at 12- and 24-month intervals

Null Hypotheses:
1. There is no difference in the prevalence of gingival bleeding around a set of index teeth in adult patients of GDPs who receive one-visit scale and polishes at six monthly intervals compared to patients who receive one-visit scale and polishes at 12- and 24-month intervals
2. There is no difference in the prevalence of visible plaque around a set of index teeth in adult patients of GDPs who receive one-visit scale and polishes at six monthly intervals, compared to patients who receive one-visit scale and polishes at 12- and 24-month intervals
3. There is no difference in the amount of calculus around a set of index teeth in adult patients of GDPs who receive one-visit scale and polishes at six monthly intervals compared to patients who receive one-visit scale and polishes at 12- and 24-month intervals
4. There is no difference in the mean scores for subjectively assessed oral cleanliness of adult patients of GDPs who receive one visit scale and polishes at six monthly intervals compared to patients who receive one visit scale and polishes at 12- and 24-month intervals

Ethics approval

Approval received by Cheshire North and West Ethics Committee on 4th January 2006 (REC Reference: 05/Q1506/100).

Study design

Randomised, controlled, three-compartment, parallel interventional clinical trial. Assessor and statistician analysing clinical data both blind to allocation of group.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gingival health

Intervention

Treatment group:
After a routine dental examination, the test group (group one) will receive a supra-gingival scale and polish of teeth without any adjunctive periodontal therapy such as anti-microbial therapy or root planing. The scale and polish must be completed in one visit by a hygienist working in the practice using an ultrasonic scaler and a slow speed, air motor driven rotary rubber cup with polishing paste. Patients allocated to group one will receive a one-visit scale and polish at baseline, six months, 12 months and 18 months.

Prior to the scale and polish the hygienist will give standardised oral hygiene instruction based on The Scientific Basis of Dental Education. This intervention will be provided four times during the study; at baseline, six months, 12 months and 18 months.

Control groups - there will be two control groups:
Group two: will receive a one visit scale and polish from the hygienist at baseline and 12 months
Group three: will receive a one visit scale and polish at baseline only

Both groups will receive a routine, twice-yearly examination and the same standardised oral hygiene instruction based on The Scientific Basis of Dental Education as group one provided by the practice hygienist at the time of routine examination on a six monthly basis.

All groups will receive an outcome epidemiological examination at 24 months, immediately prior to their routine check up.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Bleeding: bleeding from gingival margin on light probing measured on a set of index teeth (Ramfjord teeth). This will be according to a dichotomous scale bleeding present\not present.

Secondary outcome measures

1. Plaque: visual presence on a set of index teeth (Ramfjord teeth). This will be according to a dichotomous scale present\not present
2. Calculus: this will involve one measurement, in millimetres using a periodontal probe, taken in the vertical axis of the tooth, on the tooth with the most calculus. The measurements will be confined to the lingual surfaces of the six mandibular incisor and canine teeth
3. Subjective assessment of oral cleanliness will be captured on a five point scale: a single, standardised question will be asked prior to the clinical examination of each participant: ‘How clean does you mouth feel on a scale of one to five, where one is the least clean you can imagine and five is the cleanest you can imagine?’

Overall trial start date

01/02/2006

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Participants must:
1. Be male and female adult patients aged between 18 to 60 years of age who are registered at either of the two dental practices on the Wirral and who have had two dental examinations in the last three years and a scale and polish in the last 18 months
2. Have the ability to understand and provide informed consent
3. Be available for the full duration of the study
4. Have a minimum of 20 teeth excluding third molars and not wear a removable prosthetic appliance

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Patients with the following characteristics will be excluded from the study:
1. Patients who in their GDP’s opinion require periodontal treatment other than a one visit scale and polish (this would normally equate to a Basic Periodontal Examination [BPE] score of more than two, i.e. three or four)
2. Patients with acute periodontal disease characterised by the presence of pain, purulent exudate, or severe tooth mobility requiring immediate treatment intervention
3. Patients with a history of rheumatic fever, valvular heart disease or any condition requiring premedication to prevent endocarditis
4. Patients with extensive caries (three or more decayed teeth, requiring more than one visit for restoration)
5. Patients with a removable prosthetic appliance, with the exception of an acrylic splint to prevent nocturnal bruxism
6. Patients with soft or hard tissue tumours of the oral cavity
7. Patients who are pregnant or lactating at the commencement of the trial
8. Patients who are receiving long-term antibiotic, oral steroidal (i.e. except inhalers), or non-steroidal anti-inflammatory drugs
9. Subjects with diabetes, haemophilia or any other medical condition requiring medical support and/or drug therapy that may interfere with the parameters being investigated
10. Involvement in any concurrent study, the nature of which may affect the parameters being investigated in this study
11. Patients who have been formally diagnosed with, and who are receiving treatment for, either Sjogren’s syndrome or a dry mouth

Recruitment start date

01/02/2006

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Manchester
Manchester
M15 6FH
United Kingdom

Sponsor information

Organisation

The University of Manchester (UK)

Sponsor details

University Research Office
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Oral Health Unit of the University of Manchester (UK) - self-funded trial

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22204658
2. 2013 patient perceptions results in: http://www.ncbi.nlm.nih.gov/pubmed/24090395

Publication citations

  1. Results

    Jones CL, Milsom KM, Ratcliffe P, Wyllie A, Macfarlane TV, Tickle M, Clinical outcomes of single-visit oral prophylaxis: a practice-based randomised controlled trial., BMC Oral Health, 2011, 11, 35, doi: 10.1186/1472-6831-11-35.

  2. Patient perceptions results

    Jones C, Macfarlane TV, Milsom KM, Ratcliffe P, Wyllie A, Tickle M, Patient perceptions regarding benefits of single visit scale and polish: a randomised controlled trial., BMC Oral Health, 2013, 13, 50, doi: 10.1186/1472-6831-13-50.

Additional files

Editorial Notes