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

Prosthesis Durability Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05289752
• Other study ID #: A17030821
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: March 16, 2023

Study information

• Verified date: February 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 16, 2023
• Est. primary completion date: August 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prosthesis Durability
• Prosthesis Failure

Intervention

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

Locations

Country	Name	City	State
Egypt	Christine Ibrahim	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of overdenture retention	measuring the clinical retention of the locator retained mandibular overdenture by forcemeter	three months
Secondary	marginal bone loss	measuring crestal bone loss around dental implants in mm by digital radiography	one year
Secondary	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
Secondary	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
Secondary	pocket depth	measuring pocket depth around dental implants in mm using periodontal probe	one year