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

NCT ID: NCT03326453

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-07-01

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.

Conditions

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Complete Edentulism

Keywords

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mini dental implant overdenture Patient satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Mini dental implant

Intervention Type DEVICE

titanium mini dental implant which diameter less than 3 mm

conventional implant

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mini dental implant

titanium mini dental implant which diameter less than 3 mm

Intervention Type DEVICE

Other Intervention Names

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narrow dental implant

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Osama Ahmed Aboelfetooh

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Osama Gaballa, MDS

Role: CONTACT

Phone: 0020127251106

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 26294416 (View on PubMed)

Other Identifiers

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CEBD-CU-2017-10-16

Identifier Type: -

Identifier Source: org_study_id