Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion in Thin Mandibular Ridge on Patient Satisfaction:

Conditions
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Complete Edentulism

Intervention / Treatment
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* Device: Mini dental implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mini Dental implant<br>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. | Device: Mini dental implant<br>* titanium mini dental implant which diameter less than 3 mm<br>* Other names: narrow dental implant;|
| No Intervention: conventional implant<br>two 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone height change | measure the amount of bone height change in (millimetres) of all implant placed by DIGORA® X ray and Calliper device. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mini dental implant, overdenture, Patient satisfaction