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

March 11, 2022 updated by: Mansoura University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, P.O.Box:35516
        • Christine Ibrahim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
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
Two interforaminal implants were placed in the canine region
Device: overdenture 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
Active Comparator: Study group
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
Two interforaminal implants were placed in the canine region
Device: overdenture 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

September 20, 2021

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A03110220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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