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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Prosthesis Durability

Intervention / Treatment
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* Procedure: dental implants in the mandible
* Device: locator attachment and overdenture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>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<br>* placement of two interforaminal dental implants in the canine region in the mandible<br>Device: locator attachment and overdenture<br>* placement of locator attachment and insertion of mandibular overdenture<br>|
| Active Comparator: Group II<br>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<br>* placement of two interforaminal dental implants in the canine region in the mandible<br>Device: locator attachment and overdenture<br>* placement of locator attachment and insertion of mandibular overdenture<br>|

What is the study measuring?
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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 |