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Comparative clinical study of conventional implants and mini dental implants for retaining lower complete dentures: A randomized clinical trial

Comparative clinical study of conventional implants and mini dental implants for retaining lower complete dentures: A randomized clinical

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20160401002
Enrollment
Unknown
Registered
2016-04-01
Start date
2014-01-08
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Bone loss patient&#44

Interventions

Four mini dental implants (diameter = 3.0 mm. length = 12 mm. will be placed in the anterior mandible (interforaminal region)
subsequently&#44
Resonance Frequency Analysis (RFA) and digital periapical radiographs will be recorded
the denture will be connected to the implants immediately.,Two mini dental implants (diameter = 3.0 mm. length = 12 mm.) will be placed in the anterior mandible (canine region)
RFA and digital periapical radiographs will be recorded
the denture will be connected to the implants immediately.,Two conventional dental implants (diameter = 3.75 mm. length = 10 mm.) will be placed in the anterior mandible (canine region)
RFA and digital periapical radiographs will be recorded. Patients in this group will resume the use of the denture two weeks after stage I surgery. Mandibular dentures will be relined with a soft re&#
liner. Stage II surgery and denture connection to the implants will occur after three months.

Sponsors

Faculty of Dentistry, Chiang Mai University
Lead Sponsor
Faculty of Dentistry&#44
Collaborator
Chiang Mai University
Collaborator

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: Male and female patients were recruited according to the inclusion and exclusion criteria as following Inclusion criteria: 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 Inclusion criteria: 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

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
radiographic bone level changes 1 year Digital imaging

Secondary

MeasureTime frame
Patient satisfaction 1 year Visual analog scale,Prosthodontic complication 1 year observation and record

Countries

Thailand

Contacts

Public ContactPathawee Khongkhunthian

Faculty of Dentistry

pathweek@gmail.com081806393

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026