Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture
Primary Purpose
Vertical Alveolar Bone Loss
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
surgical placement of long dental implants
overdenture supported by RTX attachment system
Sponsored by
About this trial
This is an interventional treatment trial for Vertical Alveolar Bone Loss
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.
Sites / Locations
- Christine Ibrahim
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control group
Study group
Arm Description
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.
Outcomes
Primary Outcome Measures
Marginal bone loss
evaluations of crestal bone loss in mm around implants by digital periapical radiography
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.
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.
pocket depth
evaluation of pocket depth in mm around RTX attachments
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05290376
Brief Title
Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture
Official Title
Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture Using Two Loading Protocols
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
September 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertical Alveolar Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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;
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol.
Intervention Type
Procedure
Intervention Name(s)
surgical placement of long dental implants
Intervention Description
Two interforaminal implants were placed in the canine region
Intervention Type
Device
Intervention Name(s)
overdenture supported by RTX attachment system
Intervention Description
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 Outcome Measure Information:
Title
Marginal bone loss
Description
evaluations of crestal bone loss in mm around implants by digital periapical radiography
Time Frame
one year
Title
plaque score
Description
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.
Time Frame
one year
Title
gingival index
Description
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.
Time Frame
one year
Title
pocket depth
Description
evaluation of pocket depth in mm around RTX attachments
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Christine Ibrahim
City
Mansoura
ZIP/Postal Code
P.O.Box:35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture
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