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

Not Applicable
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
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mini Dental implantMini dental implant2 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
NameTimeMethod
patients satisfactionafter 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
NameTimeMethod
Bone height changebaseline (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.

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