Comparative clinical study of conventional implants and mini dental implants for retaining lower complete dentures: A randomized clinical trial
- Conditions
- Bone loss patient,patient satisfaction,prosthodontic complication
- Registration Number
- TCTR20160401002
- Lead Sponsor
- Faculty of Dentistry, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Male and female patients were recruited according to the inclusion and exclusion criteria as following
General
1.Completely edentulous arches, requiring complete dentures
2.No contraindication for minor oral surgery (ASA ≤ 2)
3.No psychosis, dementia, or other psychiatric disorders
4.No uncontrolled bleeding disorders
5.No smoking or smoking of less than 10 cigarettes /day during the last five years (questionnaire)
6.No intravenous injection of bisphosphonate drugs
7.Never received radiotherapy of the mandibular or cervical regions
8.Ability to maintain good oral health, denture and dental implant care
9.Good attitude for denture insertion and understanding of treatment procedures
10.To be able and to agree to undergo treatment and follow up at least 7- 10 times
Dental
1.Maxillary complete denture must have good marginal fit and retention with acceptable esthetics.
2.Mandibular complete denture must have proper marginal fit and its thickness at the areas of the implants must be at least 6 mm.
3.Occlusal plane of denture should be parallel to interpupillary line, ala-tragus line and no severe occlusal interference
4.Oral hard and soft tissues without pathoses
5.Implant site must reveal a zone of at least 4 mm of keratinized mucosal width. (the keratinized mucosal width may be corrected simultaneously with the implant installation: vestibuloplasty / free gingival grafts)
6.Alveolar ridge width of at least 6 mm (measuring point 5 mm below the alveolar crest) is required at the implant site (labio-lingual dimension).
7.Alveolar ridge height of at least 14 mm is required at the implant site (vertical dimension).
Exclusion criteria
1.Conditions that would prevent completion of study participation
2.Conditions requiring chronic routine use of antibiotics or requiring prolonged use of steroids
3.History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection
4.Alcoholism or drug abuse and heavy smoking (> 10 cigarettes a day)
5.Pregnancy
6.Erosive lichen planus or other diseases / lesions of the oral mucosa
7.Local irradiation history
8.Intraoral infection
9.Inadequate oral hygiene
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method radiographic bone level changes 1 year Digital imaging
- Secondary Outcome Measures
Name Time Method Patient satisfaction 1 year Visual analog scale,Prosthodontic complication 1 year observation and record