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Clinical Trials/NCT06401200
NCT06401200
Completed
Not Applicable

Marginal Bone Loss and Soft Tissue Health Around Implants in Selective Laser Melted Versus Milled Cobalt Chromium Bar Retained Mandibular Overdenture:(Randomized Controlled Trial)

Minia University1 site in 1 country20 target enrollmentNovember 15, 2022
ConditionsDental

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental
Sponsor
Minia University
Enrollment
20
Locations
1
Primary Endpoint
Radiographic Evaluation (Vertical Marginal bone loss in millimeters)
Status
Completed
Last Updated
last year

Overview

Brief Summary

the aim of this study was to assess the marginal bone loss and soft tissue outcomes of milled and selective laser melted cobalt chromium bar retaining implant mandibular overdenture. Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.

Detailed Description

Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
January 5, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Minia University
Responsible Party
Principal Investigator
Principal Investigator

Reem Abd El Moatty Abd El Monem

lecturer assistant

Minia University

Eligibility Criteria

Inclusion Criteria

  • completely edentulous patient.
  • age range (50-60) years old.
  • adequate bone volume in canine area bilaterally to receive implant of 3.7 mm diameter and 13mm length verified by CBCT for all patients.
  • sufficient inter arch space (13-14mm) to accommodate bar construction
  • normal maxillo-mandibular relation-ship
  • (Angel's class I)
  • proper oral hygiene

Exclusion Criteria

  • patients with metabolic or systemic disease that may affect osseointegration.
  • history of radiation therapy.
  • history of bisphosphonate intake
  • heavy smoking and bad habits as bruxism.

Outcomes

Primary Outcomes

Radiographic Evaluation (Vertical Marginal bone loss in millimeters)

Time Frame: at 6 and 12 months

using periapical x-ray with parallel long cone technique from implant shoulder till bony crest

Secondary Outcomes

  • modified Plaque Index.(at 0,6 and 12 months follow up)
  • modified Gingival Index(at base line, 6 and 12 months)
  • Probing depth in millimeters.(at 0,6 and 12 months)

Study Sites (1)

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