NCT06401200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

April 30, 2024

Last Update Submit

May 7, 2024

Conditions

Dental

Keywords

SLMMilledBar overdenture

Outcome Measures

Primary Outcomes (1)

  • Radiographic Evaluation (Vertical Marginal bone loss in millimeters)

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

    at 6 and 12 months

Secondary Outcomes (3)

  • Probing depth in millimeters.

    at 0,6 and 12 months

  • modified Plaque Index.

    at 0,6 and 12 months follow up

  • modified Gingival Index

    at base line, 6 and 12 months

Study Arms (2)

group 1: milled cobalt chromium bar

ACTIVE COMPARATOR

10 completely edentulous patients received two implants at canine region bilaterally (3.7mm diameter- 13mm length), within two weeks after surgery (following early loading protocol), an open tray impression technique was made for bar construction which was designed according to randomization patient enrollment

Other: bar retained implant overdenture

group 2: Selective laser melted cobalt chromium bar

EXPERIMENTAL

10 completely edentulous patients received two implants at canine region bilaterally (3.7mm diameter- 13mm length), within two weeks after surgery (following early loading protocol), an open tray impression technique was made for bar construction which was designed according to randomization patient enrollment

Other: bar retained implant overdenture

Interventions

bar retained implant overdentureOTHER

use of bar attachment in completely edentulous patient

Also known as: bar attachment implant mandibular overdenture
group 1: milled cobalt chromium bargroup 2: Selective laser melted cobalt chromium bar

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Minya Governorate, 61511, Egypt

Location

Related Publications (1)

  • El-Asfahani IA, Abd El-Moatty R, Mohamed GF, Hussein HA. Marginal bone loss and soft tissue health around two-implant mandibular overdenture retained with milled versus selective laser melted cobalt chromium bar: a randomized clinical trial. BMC Oral Health. 2024 Oct 4;24(1):1180. doi: 10.1186/s12903-024-04883-6.

    PMID: 39367394DERIVED

Study Officials

  • Eman A Asfahani, PHD

    Minia University

    STUDY CHAIR

  • Hussein A Elhady, PHD

    Minia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistant

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 6, 2024

Study Start

November 15, 2022

Primary Completion

December 27, 2023

Study Completion

January 5, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

EG(1)