Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion
- Conditions
- Complete Edentulism
- Interventions
- Device: Mini dental implant
- Registration Number
- NCT03326453
- Lead Sponsor
- Cairo University
- 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?
- Detailed Description
PICO
P: Completely edentulous Patients.
I: Mandibular overdenture supported by mini dental implant.
C: Mandibular overdenture supported by conventional implant diameter after bone expansion.
O: outcomes as follows:
Primary Outcome: Patient satisfaction, Questionnaire Visual analog scale (VAS), Measuring unit: Mm. (Geckili et al.
Secondary Outcome: Bone height change, Measuring device: DIGORA® X ray, Measuring unit: Mm.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mini Dental implant Mini dental implant 2 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.
- Primary Outcome Measures
Name Time Method patients satisfaction after six months of over denture insertion Visual analogue scale: a scale from 0-10 where 0 represents unsatisfied and 10 represents highly satisfied.
- Secondary Outcome Measures
Name Time Method 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 measure the amount of bone height change in (millimetres) of all implant placed by DIGORA® X ray and Calliper device.