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

Complete Edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03326453
• Other study ID #: CEBD-CU-2017-10-16
• Status: Not yet recruiting
• Phase: N/A
• First received: October 12, 2017
• Last updated: October 26, 2017
• Start date: November 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2017
• Source: Cairo University
• Contact: Osama Gaballa, MDS
• Phone: 0020127251106
• Email: osama.gaballa86[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: July 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete Edentulism

Intervention

Device:
• Mini dental implant
titanium mini dental implant which diameter less than 3 mm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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