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

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

2020-01-15

Study Completion Date

2021-09-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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Vertical Alveolar Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The selected patients were stratified according to age, gender, years of mandibular edentulism, number of old non-satisfactory dentures (baseline criteria, table 1). Patients were assigned to one of 2 groups using a balanced randomization procedure to ensure comparability between groups regarding baseline characters;

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

surgical placement of long dental implants

Intervention Type PROCEDURE

Two interforaminal implants were placed in the canine region

overdenture supported by RTX attachment system

Intervention Type DEVICE

Control group: Implants were loaded after three months by RTX supported overdenture study group: Implants were loaded after four weeks by RTX supported overdenture

Study group

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

Group Type ACTIVE_COMPARATOR

surgical placement of long dental implants

Intervention Type PROCEDURE

Two interforaminal implants were placed in the canine region

overdenture supported by RTX attachment system

Intervention Type DEVICE

Control group: Implants were loaded after three months by RTX supported overdenture study group: Implants were loaded after four weeks by RTX supported overdenture

Interventions

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surgical placement of long dental implants

Two interforaminal implants were placed in the canine region

Intervention Type PROCEDURE

overdenture supported by RTX attachment system

Control group: Implants were loaded after three months by RTX supported overdenture study group: Implants were loaded after four weeks by RTX supported overdenture

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes