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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05290376
Enrollment
30
Registered
2022-03-22
Start date
2020-01-15
Completion date
2021-09-20
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertical Alveolar Bone Loss

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.

Interventions

PROCEDUREsurgical placement of long dental implants

Two interforaminal implants were placed in the canine region

DEVICEoverdenture 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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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;

Intervention 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
gingival indexone yearevaluation 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 depthone yearevaluation of pocket depth in mm around RTX attachments
Marginal bone lossone yearevaluations of crestal bone loss in mm around implants by digital periapical radiography
plaque scoreone yearevaluation 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026