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

Not Applicable

Completed

• Conditions: Vertical Alveolar Bone Loss
• Interventions: Procedure: surgical placement of long dental implants; Device: overdenture supported by RTX attachment system

• Registration Number: NCT05290376
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-15
• Primary Completion: 2020-12-15
• Study Completion: 2021-09-20
• Status Verified: 2021-12
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-03-11
• Last Update Submitted: 2022-03-11
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	surgical placement of long dental implants	Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol
Study group	overdenture supported by RTX attachment system	Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol.
Control group	overdenture supported by RTX attachment system	Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol
Study group	surgical placement of long dental implants	Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol.

Primary Outcome Measures

Name	Time	Method
gingival index	one year	evaluation of gingival bleeding around RTX attachments using scores.0; no bleeding when a periodontal probe is passed along the mucosal margin, 1;isolated bleeding spots visible, 2; blood forms a confluent red line on the mucosal margin, 3;heavy or profuse bleeding.
pocket depth	one year	evaluation of pocket depth in mm around RTX attachments
plaque score	one year	evaluation of plaque accumulation around RTX attachments using scores.score 0; absence plaque , score 1; plaque only detected by a probe passing through the smooth marginal surface of the implant, score 2; plaque can be recognized by naked eye, and score 3; plenty of soft matter.
Marginal bone loss	one year	evaluations of crestal bone loss in mm around implants by digital periapical radiography

Trial Locations

Locations (1)

Christine Ibrahim; 🇪🇬 Mansoura, Egypt