Effect of Implant Position on Clinical Outcomes

NCT06166316 | Completed

• 1 other identifier: A01011023RP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Loss; Patient Satisfaction

Keywords

peri-implant; retention; overdenture; patient satisfaction

Outcome Measures

Primary Outcomes (5)

• peri-implant plaque

  modified plaque index

  3 years

• 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

• patient satisfaction

  Assessment of patient satisfaction and Oral Health-Related Quality of Life: using a visual analog scale (VAS) questionnaire

  3 years

Secondary Outcomes (1)

• bone loss

  3 years

Study Arms (3)

lateral incisor group

ACTIVE COMPARATOR

patients having mandibular two implants in lateral incisor positions.

Device: overdenture retained by locator attachments.

canine group

ACTIVE COMPARATOR

patients having mandibular two implants in the canine positions.

Device: overdenture retained by locator attachments.

premolar group

ACTIVE COMPARATOR

patients having mandibular two implants in the premolar positions.

Device: overdenture retained by locator attachments.

Interventions

overdenture retained by locator attachments. DEVICE

• Implant-retained overdenture construction procedures: 1. Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin. 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.

canine group; lateral incisor group; premolar group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Khloud Ezzat

Al Mansurah, 54790, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Patient Satisfaction

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Khloud Ezzat, PhD

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 12, 2023
• Study Start: January 10, 2020
• Primary Completion: January 30, 2023
• Study Completion: October 1, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)