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CompletedNCT06166316Updated Dec 20, 2023

Effect of Implant Position on Clinical Outcomes

An interventional study of overdenture retained by locator attachments. in Bone Loss and Patient Satisfaction, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Jan 2020, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Bone Loss
  • Patient Satisfaction

Keywords

  • peri-implant
  • retention
  • overdenture
  • patient satisfaction
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    lateral incisor group

    patients having mandibular two implants in lateral incisor positions.

    Device: overdenture retained by locator attachments.

  • Active comparator
    canine group

    patients having mandibular two implants in the canine positions.

    Device: overdenture retained by locator attachments.

  • Active comparator
    premolar group

    patients having mandibular two implants in the premolar positions.

    Device: overdenture retained by locator attachments.

Interventions

  • Deviceoverdenture retained by locator attachments.

    • 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.

06

What researchers measure

Primary outcomes

  1. peri-implant plaque

    modified plaque index

    Time frame: 3 years

  2. peri-implant bleeding

    bleeding index

    Time frame: 3years

  3. peri-implant probing depth

    measurements of probing depth in mm

    Time frame: 3 years

  4. overdenture retention

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

    Time frame: 3 years

  5. patient satisfaction

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

    Time frame: 3 years

Secondary outcomes

  1. bone loss

    evaluation of the peri-implant bone loss in mm

    Time frame: 3 years

07

Study locations

1 site
  • Khloud Ezzat
    Mansoura, 54790, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06166316
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Dec 12, 2023
Start date
Jan 10, 2020
Primary completion
Jan 30, 2023
Completion
Oct 1, 2023
Last update
Dec 20, 2023

Study contacts

Khloud Ezzat, PhD
principal investigator · Lecturer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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