Radiographic and Clinical Evaluation In Bar

NCT ID: NCT06401200

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-01-05

Brief Summary

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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

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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.

Conditions

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Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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group 1: milled cobalt chromium bar

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

Group Type ACTIVE_COMPARATOR

bar retained implant overdenture

Intervention Type OTHER

use of bar attachment in completely edentulous patient

group 2: Selective laser melted cobalt chromium bar

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

Group Type EXPERIMENTAL

bar retained implant overdenture

Intervention Type OTHER

use of bar attachment in completely edentulous patient

Interventions

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bar retained implant overdenture

use of bar attachment in completely edentulous patient

Intervention Type OTHER

Other Intervention Names

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bar attachment implant mandibular overdenture

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Reem Abd El Moatty Abd El Monem

lecturer assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman A Asfahani, PHD

Role: STUDY_CHAIR

Minia University

Hussein A Elhady, PHD

Role: STUDY_CHAIR

Minia University

Locations

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Minia University

Minya, Minya Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 39367394 (View on PubMed)

Other Identifiers

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Iman Adel Asfahani

Identifier Type: OTHER

Identifier Source: secondary_id

Hussein Abd Elhady

Identifier Type: OTHER

Identifier Source: secondary_id

636

Identifier Type: -

Identifier Source: org_study_id

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