Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture

Mansoura University

Status: Completed

Conditions: Vertical Alveolar Bone Loss

Treatments: Device: overdenture supported by RTX attachment system; Procedure: surgical placement of long dental implants

Study type: Interventional

Funder types: Other

Identifiers

NCT05290376

A03110220

Details and patient eligibility

About

This study was conducted to clinically and radiographically evaluate locator RTx attachments for two implant-supported mandibular overdenture using two loading protocols

Full description

Thirty edentulous patients received two implants in the interformaninal region in the canine area . According to the loading protocol used for attaching mandibular overdenture, patients were randomly assigned into two equal groups. Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol. Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol. Peri-implant tissue health [Plaque (PL) and (GI) gingival scores, pocket depth (PD), and crestal bone loss (CBL)] were evaluated immediately after denture insertion (T0), 6 (T6), and 12 (T12) months after insertion.

Enrollment: 30 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adequate bone quantity [class III -V according to Cawood and Howell in the interforaminal area of the mandible to receive 2 implants (4×13 mm)
• adequate restorative space [12-15 mm from the mucosa of the mandibular ridge to the occlusal plane, Class I according to Ahuja and Cagna for RTX supported implant overdenture.

Exclusion criteria

• systemic diseases that contraindicate implant placement
• bone metabolic diseases as diabetes mellitus
• irradiation of the head and neck region
• chemotherapy within the past 3 years
• smoking habits.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Control group

Active Comparator group

Description:

Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol

Treatment:

Device: overdenture supported by RTX attachment system

Procedure: surgical placement of long dental implants

Study group

Active Comparator group

Description:

Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol.

Treatment:

Device: overdenture supported by RTX attachment system

Procedure: surgical placement of long dental implants