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

Not Applicable

Completed

• Conditions: Prosthesis Durability
• Interventions: Procedure: dental implants in the mandible; Device: locator attachment and overdenture

• Registration Number: NCT05289752
• Lead Sponsor: Mansoura University

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-08-30
• Study First Submitted: 2022-02-27
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-21
• Primary Completion: 2022-08-07
• Status Verified: 2023-02
• Study Completion: 2023-03-16
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I	dental implants in the mandible	GroupI: The retentive caps will be picked up by the indirect method on the cast first, then by the direct method.
Group II	dental implants in the mandible	GroupII: The retentive caps will be picked up by the direct method on the cast first, then by the indirect method.
Group I	locator attachment and overdenture	GroupI: The retentive caps will be picked up by the indirect method on the cast first, then by the direct method.
Group II	locator attachment and overdenture	GroupII: The retentive caps will be picked up by the direct method on the cast first, then by the indirect method.

Primary Outcome Measures

Name	Time	Method
measurement of overdenture retention	three months	measuring the clinical retention of the locator retained mandibular overdenture by forcemeter

Secondary Outcome Measures

Name	Time	Method
marginal bone loss	one year	measuring crestal bone loss around dental implants in mm by digital radiography
plaque index	one year	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.
gingival index	one year	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
pocket depth	one year	measuring pocket depth around dental implants in mm using periodontal probe

Trial Locations

Locations (1)

Christine Ibrahim; 🇪🇬 Mansoura, Egypt