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

Damascus University

Status: Completed

Conditions: Problem With Dentures

Treatments: Other: implant-supported mandibular overdenture

Study type: Interventional

Funder types: Other

Identifiers

NCT03866031

UDDS-RemPro-01-2019

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 36 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

M:2.75

Experimental group

Description:

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

Treatment:

Other: implant-supported mandibular overdenture

M3.25

Experimental group

Description:

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

Treatment:

Other: implant-supported mandibular overdenture

S3.75

Experimental group

Description:

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

Treatment:

Other: implant-supported mandibular overdenture