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

Primary Purpose

Prosthesis Durability

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
dental implants in the mandible
locator attachment and overdenture
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthesis Durability

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Christine Ibrahim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

marginal bone loss
measuring crestal bone loss around dental implants in mm by digital radiography
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.
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
pocket depth
measuring pocket depth around dental implants in mm using periodontal probe

Full Information

First Posted
February 27, 2022
Last Updated
April 19, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05289752
Brief Title
Direct Versus Indirect Pick up of the Locator Retentive Caps:(Within-patient Study)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
August 7, 2022 (Actual)
Study Completion Date
March 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Durability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
GroupI: The retentive caps will be picked up by the indirect method on the cast first, then by the direct method.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
GroupII: The retentive caps will be picked up by the direct method on the cast first, then by the indirect method.
Intervention Type
Procedure
Intervention Name(s)
dental implants in the mandible
Intervention Description
placement of two interforaminal dental implants in the canine region in the mandible
Intervention Type
Device
Intervention Name(s)
locator attachment and overdenture
Intervention Description
placement of locator attachment and insertion of mandibular overdenture
Primary Outcome Measure Information:
Title
measurement of overdenture retention
Description
measuring the clinical retention of the locator retained mandibular overdenture by forcemeter
Time Frame
three months
Secondary Outcome Measure Information:
Title
marginal bone loss
Description
measuring crestal bone loss around dental implants in mm by digital radiography
Time Frame
one year
Title
plaque index
Description
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
Title
gingival index
Description
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
Title
pocket depth
Description
measuring pocket depth around dental implants in mm using periodontal probe
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Christine Ibrahim
City
Mansoura
ZIP/Postal Code
P.O.Box:35516
Country
Egypt

12. IPD Sharing Statement

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

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