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Patients’ satisfaction when wearing different dentures - a pilot study

Patients satisfaction and quality life assessment when wearing complete dentures with teeth of different anatomical designs: a randomised controlled crossover pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12769138
Enrollment
20
Registered
2017-03-20
Start date
2017-04-01
Completion date
Unknown
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete tooth loss (edentulism) Oral Health Complete tooth loss (edentulism)

Interventions

The patients will be randomised into 2 groups via a computerised block envelope process. This was done by using the website www.sealedenvelope.com . The two groups are named Group A and Group B. Group

Sponsors

Queen Mary University of London, Barts & The London Dental School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Informed consent 2. Age 18-100 years 3. Any gender 4. Any ethnicity 5. Successful denture wearers (i.e. previous denture wearing experience – 3+ years) who need new dentures 6. No mental health issues 7. No problems of Xerostomia (dry mouth).

Exclusion criteria

Exclusion criteria: 1. Any inclusion criteria not met 2. Under 18 years 3. The shape and size of the jaw bones - Any Cawood and Atwood classification that is other than Class 2 or 3 or 4: Class 2 = a bone shape that is well rounded and of good height but with the remnants of a socket due to tooth being recently removed Class 3 = a bone shape that is well rounded and of good height. Class 4 = a bone shape that is knife edged and of reasonable height. 4. Unable to consent 5. Pregnant patients. 6. Patients unable to attend easily due to locality or occupation limitations. 7. Large skeletal base discrepancies. This relates to the positioning of the upper and lower jaw to each other. A large skeletal discrepancy would include the lower jaw being too far forward in relation to the upper jaw. Also the contrary where the lower jaw is too far back in relation to the upper jaw. These are called Class 3 and Class 2 Skeletal base relationships respectively. 8. Severe fibrous replacement. This means that there is an area of the oral tissue upon which the denture may be seated on where it has excess fibrous/scar tissue. 9. Maxillo-facial defects. The subject may have undergone surgery or have existing defects to the jaws or face due to multiple reasons such as tumours, cysts, trauma to the face and developmental facial defects. These can change the anatomy of the area where the dentures rely on heavily and can influence the trial.

Design outcomes

Primary

MeasureTime frame
Patient satisfaction is assessed using Professor Fenlon's patient satisfaction with dentures questionnaire at the start and end of each two-month treatment period.

Secondary

MeasureTime frame
1. Quality of life is measured using the OHIP-EDENT questionnaire at the start and end of each two-month treatment period 2. Self-assessed chewing ability is measured using a questionnaire at the start and end of each two-month treatment period 3. Self-assessed aesthetics of each set of dentures is rated by patients using a questionnaire at the end of each two-month treatment period

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026