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

Study Overview
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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

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.

Official Title
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Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture Using Two Loading Protocols

Conditions
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Vertical Alveolar Bone Loss

Intervention / Treatment
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* Procedure: surgical placement of long dental implants
* Device: overdenture supported by RTX attachment system


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol | Procedure: surgical placement of long dental implants<br>* Two interforaminal implants were placed in the canine region<br>Device: overdenture supported by RTX attachment system<br>* Control group: Implants were loaded after three months by RTX supported overdenture study group: Implants were loaded after four weeks by RTX supported overdenture<br>|
| Active Comparator: Study group<br>Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol. | Procedure: surgical placement of long dental implants<br>* Two interforaminal implants were placed in the canine region<br>Device: overdenture supported by RTX attachment system<br>* Control group: Implants were loaded after three months by RTX supported overdenture study group: Implants were loaded after four weeks by RTX supported overdenture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | evaluations of crestal bone loss in mm around implants by digital periapical radiography | one year | 
| plaque score | 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. | one year | 
| gingival index | 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. | one year | 
| pocket depth | evaluation of pocket depth in mm around RTX attachments | one year |