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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03326453

Enrollment

Registered

2017-10-31

Start date

2017-11-01

Completion date

2019-07-01

Last updated

2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete Edentulism

Keywords

mini dental implant, overdenture, Patient satisfaction

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.

Interventions

DEVICEMini dental implant

titanium mini dental implant which diameter less than 3 mm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

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.

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactOsama Gaballa, MDS

osama.gaballa86@gmail.com0020127251106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026