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Completed

NCT Number: NCT06166316

Effect of Implant Position on Clinical Outcomes

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khloud Ezzat

Al Mansurah, 54790, Egypt

About this 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.

  • 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:
  • 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.
  • 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

overdenture retained by locator attachments.

Device
  • 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.

Primary outcomes

  1. peri-implant plaque

    Time frame: 3 years

    modified plaque index

  2. peri-implant bleeding

    Time frame: 3years

    bleeding index

  3. peri-implant probing depth

    Time frame: 3 years

    measurements of probing depth in mm

  4. overdenture retention

    Time frame: 3 years

    Measurements of retention values: using the device of measuring the clinical retentive forces

  5. patient satisfaction

    Time frame: 3 years

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

Secondary outcomes

  1. bone loss

    Time frame: 3 years

    evaluation of the peri-implant bone loss in mm

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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