Effect of Implant Position on Clinical Outcomes

Effect of Implant Position on Clinical Outcomes of Implant-retained Mandibular Overdenture. A 3-year Retrospective Study

the study aims to investigate the clinical influence of different implant locations; lateral incisor, canine, and first premolar areas; supporting 2-implant retained mandibular over-dentures with locator attachment on prosthesis retention and peri-implant health.

Study Overview

• Status: Completed
• Conditions: Bone Loss; Patient Satisfaction
• Intervention / Treatment: Device: overdenture retained by locator attachments.

Detailed Description

the study aims to investigate the clinical influence of different implant locations; lateral incisor, canine, and first premolar areas; supporting 2-implant retained mandibular over-dentures with locator attachment on prosthesis retention and peri-implant health.

• Thirty-six edentulous patients will be recalled from the database set of the clinic of the removable prosthodontic department, Faculty of Dentistry, Mansoura University. Patients will be recruited from previous studies, having two-implant mandibular overdentures.
• All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.
• The patients will be grouped based on the implant position:

Group I (12 patients): patients having mandibular two implants in lateral incisor positions.

Group II (12 patients): patients having mandibular two implants in the canine positions.

Group III (12 patients): patients having mandibular two implants in the premolar positions.

• Implant-retained overdenture construction procedures:

  1. Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin. The mandibular tray was fabricated with holes above the implant sites and molded with green impression compound modeling plastic.
  2. Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.
  3. Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.

  4. The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing.

     Method of evaluation

• Assessment of the peri-implant soft tissue health including Plaque index, Probing depth, and bleeding index. Also, evaluation of the peri-implant bone loss was done at one, two, and three years after insertion using a CBCT, following the methodology described by Elsyad et al.
• Measurements of retention values: using the device of measuring the clinical retentive forces.
• Assessment of patient satisfaction and Oral Health-Related Quality of Life: using a visual analog scale (VAS) questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 54790
    • Khloud Ezzat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• mandibular two implants retained overdenture opposing complete edentulous maxillary arch.
• patients who attended the previous follow-up recalls with previous CBCT examination

Exclusion Criteria:

• Patients who didn't attend previous follow-up recalls.
• patients who didn't perform radiographic follow-up.
• patients who had para-functional habits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lateral incisor group; patients having mandibular two implants in lateral incisor positions.	Device: overdenture retained by locator attachments.; • Implant-retained overdenture construction procedures: Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin.; Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.; Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.; The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing.
Active Comparator: canine group; patients having mandibular two implants in the canine positions.	Device: overdenture retained by locator attachments.; • Implant-retained overdenture construction procedures: Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin.; Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.; Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.; The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing.
Active Comparator: premolar group; patients having mandibular two implants in the premolar positions.	Device: overdenture retained by locator attachments.; • Implant-retained overdenture construction procedures: Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin.; Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.; Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.; The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peri-implant bleeding	bleeding index	3years
peri-implant probing depth	measurements of probing depth in mm	3 years
overdenture retention	Measurements of retention values: using the device of measuring the clinical retentive forces	3 years
peri-implant plaque	modified plaque index	3 years
patient satisfaction	Assessment of patient satisfaction and Oral Health-Related Quality of Life: using a visual analog scale (VAS) questionnaire	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone loss	evaluation of the peri-implant bone loss in mm	3 years

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Khloud Ezzat, PhD, lecturer

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: patient satisfaction; retention; overdenture; peri-implant
• Other Study ID Numbers: A01011023RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No