Radiographic and Clinical Evaluation In Bar

Not Applicable

Completed

• Conditions: Dental
• Interventions: Other: bar retained implant overdenture

• Registration Number: NCT06401200
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2022-11-15
• Primary Completion: 2023-12-27
• Study Completion: 2024-01-05
• Study First Submitted: 2024-04-30
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-06
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1: milled cobalt chromium bar	bar retained implant overdenture	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 2: Selective laser melted cobalt chromium bar	bar retained implant overdenture	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

Primary Outcome Measures

Name	Time	Method
Radiographic Evaluation (Vertical Marginal bone loss in millimeters)	at 6 and 12 months	using periapical x-ray with parallel long cone technique from implant shoulder till bony crest

Secondary Outcome Measures

Name	Time	Method
modified Plaque Index.	at 0,6 and 12 months follow up	using Mombelli charting scale at four aspects (mesial, distal, buccal and lingual)
modified Gingival Index	at base line, 6 and 12 months	using Apsi charting scale at four sites (mesial, distal, buccal and lingual)
Probing depth in millimeters.	at 0,6 and 12 months	using sensitive pressure plastic probe in four sites mesial, distal, buccal and lingual

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Minia, Egypt