Does Use of the Waterpik Maintain Cleaner Teeth in Patients With Fixed Braces

NCT04604262 | Terminated

• 1 other identifier: 266235
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

There is no long term evidence to show that the use of Waterpik® is effective for orthodontic patients with fixed braces. A Cochrane Systematic Review confirms this. The aims of this study is to find out if the use of Waterpik® in addition to the manual toothbrush is better to maintain clean teeth in patients with fixed braces. The null hypothesis is that there is no difference between patients using either Waterpik® in addition to the manual toothbrush (treatment group) when compared with patients using just the manual toothbrush (control group).

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (3)

• Change in Plaque index from baseline

  The patient will be disclosed by the clinical investigator who will be blind to the toothbrush group allocation. The disclosed mouth will be photographed and plaque scored at the same time. The photograph will allow for a re-score and to check the validity of the clinical score. Plaque will be assessed on the buccal surfaces of the teeth on which orthodontic brackets has been placed using the orthodontic modification of the Silness and Loe plaque index. This index has been shown to be sensitive in detecting differences in plaque levels in orthodontic patients with fixed braces. This index divides the tooth surface into four zones in relation to the orthodontic bracket: incisal, distal, mesial and cervical and codes 0-3 were assigned.

  8, 32, 56 weeks

• Change in Gingivitis from baseline

  Gingivitis will be measured on the buccal surfaces of the teeth with the gingival index using a CPITN probe.

  8, 32, 56 weeks

• Change in Gingival bleeding from baseline

  Gingival bleeding will be determined using the Eastman interdental bleeding index. This will involve inserting a wooden interdental cleaner (Interdental woodsticks, Oral-B Laboratories, Aylesbury, UK) between the teeth from the buccal aspect and depressing the interdental papilla by 1-2 mm. The presence or absence of marginal interdental bleeding from the papilla within 15 seconds will be recorded. The Eastman interdental bleeding index is the number of bleeding sites as expressed as a percentage of the total sites evaluated.

  8, 32, 56 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

Waterpik® in addition to the manual toothbrush

Device: Waterpik

Control

NO INTERVENTION

Manual toothbrush

Interventions

Waterpik DEVICE

Waterpik dental water jet

Treatment Group

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

1. All patients will have a dental history that included brushing at least twice a day and be willing and able to comply with the trial regime. They will also be between 10 and 20 years of age and in good general health. Any patients with medical conditions and those necessitating chemotherapy which may alter the oral tissue's response to fixed appliance treatment will be excluded. Examples include heart conditions requiring antibiotic cover, diabetes mellitus, immunosuppressant drugs, antibiotics, steroids and hormonal therapy. 2. Patients with decreased manual dexterity either due to mental or physical disabilities and poor compliance will be excluded. Patients with poor initial periodontal health will also be excluded. 3. All medications which may alter plaque accumulation should be avoided during the trial period, but if required on professional advice should report this to the clinical investigator. 4. All patients will have brackets as opposed to bands except permanent molar teeth which may be banded. 5. The patients will have full upper and lower arch treatment as oppose to sectional arch treatment. This is so that the difficulties involved in cleaning all the teeth are similar. 6. They should be bonded using one single type of cement, as we are unsure if different types of cement would influence the accumulation of plaque. This may be true with glass ionomer cement, as it has been shown to inhibit growth of some bacteria. The cement chosen for this purpose is Transbond XT® by 3M Unitek as this the cement most familiar to the operator. Furthermore any breakages from the appliances will be repaired using this cement. This will also ensure that consistent cement will be used. 7. The fixed braces will be of the pre-adjusted Edgewise type as auxiliaries used in other appliance type may pose to be confounding factor. As this unit uses the AO Orthodontics, MBT prescription brackets, this will be the brackets used for this trial. 8. Patients who already use any other supplements to the manual toothbrush for their oral hygiene will be excluded so as not to disadvantage their oral hygiene during their trial

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• York Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

York Teaching Hospital NHS Foundation Trust

York, North Yorkshire, YO31 8HE, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent outcome assessors
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a 56-week single blind, stratified; parallel group randomised controlled clinical trial. This will be a pseudo-longitudinal trial where observations are recorded at certain fixed intervals.

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 27, 2020
• Study Start: September 1, 2019
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

GB (1)