Comparative Study of Mandibular Dentures Immediately Loaded on Implants or Mini-implants

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2022-12-12

Brief Summary

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3 groups of immediately Loaded implant-supported overdenture patients will be evaluated (overdentures supported by two standard-sized implant, overdentures supported by 4 mini implant d: 3.2 mm ,overdentures supported by 4 mini implant d: 2.75 mm) regarding stability, masticatory efficiency, patient's satisfaction, oral health related quality of life, Peri-implant crestal alveolar bone loss.

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Detailed Description

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The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.

The evaluations of the primary outcomes will be conducted before implantation and after (1 - 3 - 6 - 12 - 18), except Peri-implant crestal alveolar bone loss will be conducted only after (0 - 3 - 6 - 12 - 18).

Conditions

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Problem With Dentures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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M:2.75

12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 2.75 mm

Group Type EXPERIMENTAL

implant-supported mandibular overdenture

Intervention Type OTHER

The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.

M3.25

12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 3.25 mm

Group Type EXPERIMENTAL

implant-supported mandibular overdenture

Intervention Type OTHER

The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.

S3.75

12 Patients will be provided with 2 standard sized implant-supported mandibular overdentures d: 3.75 mm

Group Type EXPERIMENTAL

implant-supported mandibular overdenture

Intervention Type OTHER

The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.

Interventions

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implant-supported mandibular overdenture

The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. the patient should be completely edentulous for at least 6 months.
2. first class jaw relation.
3. adequate bone for an implant length of at least 10 mm and diameter of at least 2.75 mm.
4. the patients should be able to speak and write in arabic.

Exclusion Criteria

1\) patients who received radiotherapy to the head or neck region for tumors. (2) a history of chemotherapy. (3) patients on long-term steroids, or bisphosphonates. (4) heavy smokers. (5) patients with physical and mental dis -abilities that interfere with the maintenance of implants.

(6) uncontrolled systematic disease that could compromise implant surgery. (7) extreme bruxism. (8) infectious disease. (9) temporomandibular joint dysfunction.

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No