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Clinical Trials/NCT05290376
NCT05290376
Completed
Not Applicable

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

Mansoura University1 site in 1 country30 target enrollmentJanuary 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vertical Alveolar Bone Loss
Sponsor
Mansoura University
Enrollment
30
Locations
1
Primary Endpoint
gingival index
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2020
End Date
September 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

pocket depth

Time Frame: one year

evaluation of pocket depth in mm around RTX attachments

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.

Marginal bone loss

Time Frame: one year

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

Study Sites (1)

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