Clinical trial NCT03003052: Assessing Current Clinical Concepts in Dental Practice
Official title: Assessing Current Clinical Concepts in Dental Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dental Implant
Keywords: dental implants
edentulous
dental hygiene
evidence-based dentistry
Lead sponsor: The Campbell Clinic, UK
Sponsor class: INDUSTRY
First posted: 2016-12-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients treated at the Campbell Clinic, with focus on dental implants

Brief summary: This purpose of this database is to collect, store and use appropriately derived data from routine patient care in a specialist dental practice. Comprehensive observational data will be gathered, systematically organised and be continuously updated. This data will be used to evaluate treatment outcomes and identify areas for improvement. This will contribute to the existing evidence base to validate new and current clinical concepts in dentistry. Patient consent will be sought for this, and all data extracted from patient notes will be stored and used anonymously. Use of the Oral Health Impact Profile (OHIP) -14 questionnaire pre and post treatment will be used to assess patient satisfaction with outcomes.

Detailed description: Specialist dentistry uses a combination of techniques resulting from joint decisions between clinicians and patients, aimed at giving the patient what is perceived to be the best possible outcome. However, as new techniques and approaches develop, there is capacity for more evidence to justify one treatment option over another, both clinically and most importantly, from the patient perspective.

The aim of this project is to set up a research database which will enable the collection and storage of appropriately derived data from routine patient care and from patient questionnaires (using OHIP-14). This data will be used in cohort studies/case series reports/comparative studies with other practices.

It is believed that this process will provide an effective way of evidencing predictable outcomes, assist in the development of improved clinical techniques, provide additional guidance and support for patients, and further clinical research in dental practice. In addition, implementation of studies to track patient satisfaction with clinical outcomes will provide advanced support in the decision making process.

All adult patients treated at The Campbell Clinic will be approached for consent. This will be an ongoing process, to maximize sample size. Treatment decisions will be continue to be made jointly by clinician and patient and will not be altered by participation in this study. Patient consent will be sought, and all data will be anonymised for storage in the database.

Eligibility criteria: Inclusion Criteria:

1. be a patient at The Campbell Clinic
2. be planning to undergo or have undergone specialist dental treatment, usually involved dental implants
3. be able to read and understand Patient Information Sheet
4. Have signed informed consent form

Exclusion Criteria:

1. concern that patient has not understood patient information sheet (e.g. due to language /interpretation issues)
2. not willing to sign consent form
3. any medical condition/medication that might compromise implant success

Primary outcomes:
measure: Implant Success - clinical measures
timeFrame: up to 4 years
Secondary outcomes:
measure: Implant Success - patient defined
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: The Campbell Clinic
Study officials:
affiliation: The Campbell Clinic
name: Colin Campbell
role: PRINCIPAL_INVESTIGATOR
References: