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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05289752
Enrollment
30
Registered
2022-03-21
Start date
2021-08-30
Completion date
2023-03-16
Last updated
2023-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthesis Durability

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.

Interventions

PROCEDUREdental implants in the mandible

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

DEVICElocator attachment and overdenture

placement of locator attachment and insertion of mandibular overdenture

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
measurement of overdenture retentionthree monthsmeasuring the clinical retention of the locator retained mandibular overdenture by forcemeter

Secondary

MeasureTime frameDescription
marginal bone lossone yearmeasuring crestal bone loss around dental implants in mm by digital radiography
plaque indexone yearmeasuring 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 indexone yearmeasuring 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 depthone yearmeasuring pocket depth around dental implants in mm using periodontal probe

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026