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Completed

NCT Number: NCT05289752

Direct Versus Indirect Pick up of the Locator Retentive Caps:(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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christine Ibrahim

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dental implants in the mandible

Procedure

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

locator attachment and overdenture

Device

placement of locator attachment and insertion of mandibular overdenture

Primary outcomes

  1. measurement of overdenture retention

    Time frame: three months

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

Secondary outcomes

  1. marginal bone loss

    Time frame: one year

    measuring crestal bone loss around dental implants in mm by digital radiography

  2. plaque index

    Time frame: one year

    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.

  3. gingival index

    Time frame: one year

    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

  4. pocket depth

    Time frame: one year

    measuring pocket depth around dental implants in mm using periodontal probe

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 21, 2022
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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