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

Mansoura University30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vertical Alveolar Bone Loss

Interventions

surgical placement of long dental implantsPROCEDURE

Two interforaminal implants were placed in the canine region

overdenture supported by RTX attachment systemDEVICE

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Christine Ibrahim

Al Mansurah, Egypt

Outcomes

Primary Outcomes

Marginal bone loss

evaluations of crestal bone loss in mm around implants by digital periapical radiography

Time frame: 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.

Time frame: 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.

Time frame: one year

pocket depth

evaluation of pocket depth in mm around RTX attachments

Time frame: one year

Data from ClinicalTrials.gov

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