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

Vertical Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290376
• Other study ID #: A03110220
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: December 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 20, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Vertical Alveolar Bone Loss

Intervention

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

Locations

Country	Name	City	State
Egypt	Christine Ibrahim	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal bone loss	evaluations of crestal bone loss in mm around implants by digital periapical radiography	one year
Primary	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
Primary	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
Primary	pocket depth	evaluation of pocket depth in mm around RTX attachments	one year