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Completed

NCT Number: NCT06401200

Radiographic and Clinical Evaluation In Bar

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.

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Key information

Conditions

Dental

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University

Minya, Minya Governorate, 61511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

bar retained implant overdenture

Other

use of bar attachment in completely edentulous patient

Other names: bar attachment implant mandibular overdenture

Primary outcomes

  1. 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

  1. Probing depth in millimeters.

    Time frame: at 0,6 and 12 months

    using sensitive pressure plastic probe in four sites mesial, distal, buccal and lingual

  2. modified Plaque Index.

    Time frame: at 0,6 and 12 months follow up

    using Mombelli charting scale at four aspects (mesial, distal, buccal and lingual)

  3. modified Gingival Index

    Time frame: at base line, 6 and 12 months

    using Apsi charting scale at four sites (mesial, distal, buccal and lingual)

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Acronym: implant

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 6, 2024
Registry last updated
May 9, 2024

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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