Direct Versus Indirect Pick up of the Locator Retentive Caps:(Within-patient Study)

NCT ID: NCT05289752

Last Updated: 2023-04-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2023-03-16

Brief Summary

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The purpose of this study will be to evaluate the effect of direct and indirect pick up of the locator retentive caps and compare the clinical results with those of the manufacturer retentive force.

Detailed Description

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Patient selection:

For this study, 30 patients were selected from the clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.

According to pick up technique for the locator retentive caps, the overdentures will be classified into two groups as follows; Group1: The retentive caps will be picked up by indirect method on the cast then by the direct method Group2: The retentive caps will be picked up in the patient by the direct method first then by the indirect method.

For both groups, the clinical retention will be measured after using pink and blue retentive inserts respectively.

All implants were inserted using computer-guided implant surgery and conventional loading protocol was used.

Evaluation methods The clinical retention of each insert will be calibrated as regards the manufacturer's value.

Also, the laboratory retention will be assessed for the two groups and calibrated as regards the manufacturer's value.

Measurements will be done immediately, three and six months after each overdenture insertion.

Conditions

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Prosthesis Durability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I

GroupI: The retentive caps will be picked up by the indirect method on the cast first, then by the direct method.

Group Type ACTIVE_COMPARATOR

dental implants in the mandible

Intervention Type PROCEDURE

placement of two interforaminal dental implants in the canine region in the mandible

locator attachment and overdenture

Intervention Type DEVICE

placement of locator attachment and insertion of mandibular overdenture

Group II

GroupII: The retentive caps will be picked up by the direct method on the cast first, then by the indirect method.

Group Type ACTIVE_COMPARATOR

dental implants in the mandible

Intervention Type PROCEDURE

placement of two interforaminal dental implants in the canine region in the mandible

locator attachment and overdenture

Intervention Type DEVICE

placement of locator attachment and insertion of mandibular overdenture

Interventions

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dental implants in the mandible

placement of two interforaminal dental implants in the canine region in the mandible

Intervention Type PROCEDURE

locator attachment and overdenture

placement of locator attachment and insertion of mandibular overdenture

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ● Free from any systemic disease that may interfere with the osseointegration of implants.

* Patients will have completely edentulous maxilla and mandible for at least 6 months after the last extraction.
* Patients will have normal maxilla mandibular relationships.
* Mandibular arch with residual alveolar ridges covered with firmly attached mucosa.
* The width of the mandibular ridge in the canine area will be sufficient for the installation of the implants in parallel anteroposterior and mesiodistal directions.

Exclusion Criteria

* medically compromised patients smokers uncontrolled metabolic diseases ( diabetes mellitus ) uncooperative patients
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Christine Ibrahim

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A17030821

Identifier Type: -

Identifier Source: org_study_id

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