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

NCT05290376 | Completed DMC

• 1 other identifier: A03110220
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vertical Alveolar Bone Loss

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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; Device: overdenture supported by RTX attachment system

Study group

ACTIVE COMPARATOR

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; Device: overdenture supported by RTX attachment system

Interventions

surgical placement of long dental implants PROCEDURE

Two interforaminal implants were placed in the canine region

Control group; Study group

overdenture supported by RTX attachment system 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

Control group; Study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Christine Ibrahim

Al Mansurah, P.O.Box:35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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;
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: March 22, 2022
• Study Start: January 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: September 20, 2021
• Last Updated: March 22, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)