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

NCT05289752 | Completed

• 1 other identifier: A17030821
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthesis Durability

Outcome Measures

Primary Outcomes (1)

• measurement of overdenture retention

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

  three months

Secondary Outcomes (4)

• marginal bone loss

  one year

• plaque index

  one year

• gingival index

  one year

• pocket depth

  one year

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Group II

ACTIVE COMPARATOR

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

dental implants in the mandible PROCEDURE

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

Group I; Group II

locator attachment and overdenture DEVICE

placement of locator attachment and insertion of mandibular overdenture

Group I; Group II

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Christine Ibrahim

Al Mansurah, P.O.Box:35516, Egypt

Location

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Dental Implants; Denture, Overlay

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Dentures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: March 21, 2022
• Study Start: August 30, 2021
• Primary Completion: August 7, 2022
• Study Completion: March 16, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-02

Locations

EG (1)