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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT05290376

Collaborator

(none)

Enrollment

Location

Arms

20.2

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vertical Alveolar Bone Loss	Procedure: surgical placement of long dental implants Device: overdenture supported by RTX attachment system	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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;

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 15, 2020

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Sep 20, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Marginal bone loss [one year]
evaluations of crestal bone loss in mm around implants by digital periapical radiography
plaque score [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.
gingival index [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 [one year]
evaluation of pocket depth in mm around RTX attachments

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christine Ibrahim	Mansoura		Egypt	P.O.Box:35516

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mansoura University

ClinicalTrials.gov Identifier:

NCT05290376

Other Study ID Numbers:

A03110220

First Posted:

Mar 22, 2022

Last Update Posted:

Mar 22, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alveolar Bone Loss

Study Results

No Results Posted as of Mar 22, 2022