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Conventional implants vs mini implants used to retain full lower dentures

Not Applicable
Completed
Conditions
Topic: Oral and Gastrointestinal
Subtopic: Oral and Gastrointestinal (all Subtopics)
Disease: Oral & Dental
Oral Health
Dentures
Registration Number
ISRCTN87342238
Lead Sponsor
Central Manchester University Hospitals NHS Trust (CMFT) (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
44
Inclusion Criteria

1. Patient has been edentulous (no teeth at all) for at least 12 months
2. Bone height = 10mm in the interforamina region (anterior section of the mandible), therefore suitable for implant placement without bone grafting
3. Cawood and Howell Classification V and VI (severely resorbed mandible)
4. New lower denture remains unsatisfactory
5. Able to give informed consent to participate in the study
6. Aged 18 or over
Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Radiographic confirmation that the patient has insufficient mandibular bone for either procedure
2. Significant medical history contraindicating the placement of either conventional or miniimplants (e.g. bisphosphonate treatment, radiotherapy treatment, poorly controlled diabetes, longterm steriod use)
3. Current smoker, or have smoked in last six months
4. Unable to maintain adequate level of oral hygiene
5. Requires sedation for dental treatment
6. Previous failed implant treatment
7. Allergic to or unable to tolerate any of the ingredients of ?gummy jelly? (an outcome measure)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Inform a large randomised trial of conventional vs mini implants; Timepoint(s): Throughout conduct of the pilot trial, each patient is followed-up for 6 months post surgery.
Secondary Outcome Measures
NameTimeMethod
ot provided at time of registration
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