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Completed

NCT Number: NCT05290376

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

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

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Key information

Conditions

Vertical Alveolar Bone Loss

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christine Ibrahim

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

surgical placement of long dental implants

Procedure

Two interforaminal implants were placed in the canine region

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

Primary outcomes

  1. Marginal bone loss

    Time frame: one year

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

  2. 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.

  3. 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.

  4. pocket depth

    Time frame: one year

    evaluation of pocket depth in mm around RTX attachments

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 22, 2022
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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