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 GDPs 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 Sjogrens 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
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
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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.
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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.