Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
The better form of ridge will provide using wider implants that can have better abilities to with stand forces and to prevent alveolar bone loss as much as possible. Ridge expansion gained some popularity due to easiness compared to any other procedure that can gain bone. However, this treatment modality needs to be evaluated as compared to Mini Dental Implants (MDIs) over denture in thin mandibular ridge. In mandibular edentulous patients having thin ridge, does the mini implant supported over denture, compared to the conventional implant supported over denture after bone expansion affect bone height around implants?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedOctober 31, 2017
October 1, 2017
1.1 years
October 12, 2017
October 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patients satisfaction
Visual analogue scale: a scale from 0-10 where 0 represents unsatisfied and 10 represents highly satisfied.
after six months of over denture insertion
Secondary Outcomes (1)
Bone height change
baseline (T0) initial bone height (millimetres), after six months usage of over denture(T1) bone height (millimetres), then after twelve-months usage of over denture(T2) bone height. 1st period (T1-T0) after 6 months 2nd period (T2-T1) after 12 months
Study Arms (2)
Mini Dental implant
EXPERIMENTAL2 mini dental implant of diameter 2.8 mm with length 10 mm will be inserted mandiblular ridge ≥5 mm mesial to the mental foraminato support overdentures for the intervention group.
conventional implant
NO INTERVENTIONtwo slandered implant diameter 3.7 mm and length 10 mm will be placed in interforaminal region of mandiblular ridge support overdenture for the compartor group.
Interventions
titanium mini dental implant which diameter less than 3 mm
Eligibility Criteria
You may qualify if:
- Completely edentulous patients ranging from age 35 to 75 years
- Angle's Class I skeletal relationship
- Normal facial symmetry
- Cooperative patients
- Adequate inter-arch space not less than 12mm
You may not qualify if:
- Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
- Patient's with neuromuscular disorders
- Patients on chemotherapy or radiotherapy
- Severe psychiatric disorders
- Angle's class II and III skeletal relationship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (1)
de Souza RF, Ribeiro AB, Della Vecchia MP, Costa L, Cunha TR, Reis AC, Albuquerque RF Jr. Mini vs. Standard Implants for Mandibular Overdentures: A Randomized Trial. J Dent Res. 2015 Oct;94(10):1376-84. doi: 10.1177/0022034515601959. Epub 2015 Aug 20.
PMID: 26294416BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The Principal investigator ,main supervisor and co-supervisor cannot be blinded as the implant placement technique for both groups will be different. In addition during assessment of 2ry outcome (bone height change) the x-ray will reveal the difference in the shape of both types of implants thus assessor couldn't be blind.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
October 12, 2017
First Posted
October 31, 2017
Study Start
November 1, 2017
Primary Completion
December 1, 2018
Study Completion
July 1, 2019
Last Updated
October 31, 2017
Record last verified: 2017-10