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CompletedNCT05289752Updated Apr 20, 2023

Direct Versus Indirect Pick up of the Locator Retentive Caps:(Within-patient Study)

An interventional study of dental implants in the mandible and locator attachment and overdenture in Prosthesis Durability, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-20.

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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2021, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study will be to evaluate the effect of direct and indirect pick up of the locator retentive caps and compare the clinical results with those of the manufacturer retentive force.

Read the detailed description

Patient selection:

For this study, 30 patients were selected from the clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.

According to pick up technique for the locator retentive caps, the overdentures will be classified into two groups as follows; Group1: The retentive caps will be picked up by indirect method on the cast then by the direct method Group2: The retentive caps will be picked up in the patient by the direct method first then by the indirect method.

For both groups, the clinical retention will be measured after using pink and blue retentive inserts respectively.

All implants were inserted using computer-guided implant surgery and conventional loading protocol was used.

Evaluation methods The clinical retention of each insert will be calibrated as regards the manufacturer's value.

Also, the laboratory retention will be assessed for the two groups and calibrated as regards the manufacturer's value.

Measurements will be done immediately, three and six months after each overdenture insertion.

02

Conditions studied

  • Prosthesis Durability

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03

In context

Prosthesis Failure

111 studies on the registry are indexed under Prosthesis Failure; 34 are open to participants now.

This study's enrollment of 30 is below the median of 35 across 66 interventional studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

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
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • ● Free from any systemic disease that may interfere with the osseointegration of implants.

    • Patients will have completely edentulous maxilla and mandible for at least 6 months after the last extraction.
    • Patients will have normal maxilla mandibular relationships.
    • Mandibular arch with residual alveolar ridges covered with firmly attached mucosa.
    • The width of the mandibular ridge in the canine area will be sufficient for the installation of the implants in parallel anteroposterior and mesiodistal directions.

Exclusion criteria

Exclusion Criteria:

  • medically compromised patients smokers uncontrolled metabolic diseases ( diabetes mellitus ) uncooperative patients
05

Study design

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

Study arms

  • Active comparator
    Group I

    GroupI: The retentive caps will be picked up by the indirect method on the cast first, then by the direct method.

    Procedure: dental implants in the mandible · Device: locator attachment and overdenture

  • Active comparator
    Group II

    GroupII: The retentive caps will be picked up by the direct method on the cast first, then by the indirect method.

    Procedure: dental implants in the mandible · Device: locator attachment and overdenture

Interventions

  • Proceduredental implants in the mandible

    placement of two interforaminal dental implants in the canine region in the mandible

  • Devicelocator attachment and overdenture

    placement of locator attachment and insertion of mandibular overdenture

06

What researchers measure

Primary outcomes

  1. measurement of overdenture retention

    measuring the clinical retention of the locator retained mandibular overdenture by forcemeter

    Time frame: three months

Secondary outcomes

  1. marginal bone loss

    measuring crestal bone loss around dental implants in mm by digital radiography

    Time frame: one year

  2. plaque index

    measuring plaque around dental implants using scoring system: 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

  3. gingival index

    measuring gingival bleeding using scoring system: 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

  4. pocket depth

    measuring pocket depth around dental implants in mm using periodontal probe

    Time frame: one year

07

Study locations

1 site
  • Christine Ibrahim
    Mansoura, P.O.Box:35516, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05289752
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Mar 21, 2022
Start date
Aug 30, 2021
Primary completion
Aug 7, 2022
Completion
Mar 16, 2023
Last update
Apr 20, 2023

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 Feb 2023. You cannot join it, but the record below documents what was studied.

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