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

Direct Versus Indirect Pick up of the Locator Retentive Caps for Two Implant-retained Mandibular Overdenture: Calibration of the Manufacturer Retentive Force and the Clinical Retention (Within-patient Study)

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.

Study Overview

• Status: Completed
• Conditions: Prosthesis Durability
• Intervention / Treatment: Procedure: dental implants in the mandible; Device: locator attachment and overdenture

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; placement of two interforaminal dental implants in the canine region in the mandible; Device: locator attachment and overdenture; placement of locator attachment and insertion of mandibular 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; placement of two interforaminal dental implants in the canine region in the mandible; Device: locator attachment and overdenture; placement of locator attachment and insertion of mandibular overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of overdenture retention	measuring the clinical retention of the locator retained mandibular overdenture by forcemeter	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal bone loss	measuring crestal bone loss around dental implants in mm by digital radiography	one year
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.	one year
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	one year
pocket depth	measuring pocket depth around dental implants in mm using periodontal probe	one year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): August 7, 2022
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: February 27, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: A17030821

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No