Comparing Cobalt-Chromium Versus PEEK Secondary Telescopic Crowns on Implant Retained Mandibular Overdenture.

NCT06637930 | Completed DMC

• 1 other identifier: 528
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized clinical trial was to compare I- The clinical behavior of implant retained removable overdenture using telescopic retention system fabricated using CAD\\CAM techniques where the effects of the different material combinations were examined in regard to:

1. 1.Retention of the mandibular over-denture.
2. 2.Plaque accumulation, presence of calculus, bleeding tendency, health of peri-implant mucosa and probing depth.

Conditions

Edentulism

Outcome Measures

Primary Outcomes (1)

• intraoral retention force assessment in Newtons (N)

  using force gauge at the geometric center of the overdentiure

  1 year follow up

Other Outcomes (2)

• Probing depth in millimeters(mm)

  1 year follow up

• Radioghraphic marginal bone level measurement in millimeters (mm)

  1 year

Study Arms (2)

Cobalt chromium(COCR) group

EXPERIMENTAL

The secondary crowns and the framework were fabricated using milled Cobalt chromium alloy

Other: Edentulous Alveolar Ridge In Mandible

Polyetheretherketone(PEEK) Group

EXPERIMENTAL

The secondary crowns and the framework were fabricated using milled PEEK material

Other: Edentulous Alveolar Ridge In Mandible

Interventions

Edentulous Alveolar Ridge In Mandible OTHER

implant retained mandibular overdenture using telescopic attachment system. all the patients received 2 implants at the canine region bilaterally using sterelithographic guide , then healing period for 3 months for proper osseointegration , then digital intraoral scanning was performed to detect implant position using scannable bodies , abutments which act as primary crowns were designed on cad software then milled using premilled titanium abutments.the study grouping was performed then virtual model was done for the designing of the frameworks then milled according to the grouping of the study. Try in of the frameworks was done and overdentures were inserted. * Retention force test was done using digital force gauge. * Probing depth using Teflon coated periodontal probe. * Marginal bone level and bone density were measured using digital periapical x-ray

Cobalt chromium(COCR) group; Polyetheretherketone(PEEK) Group

Eligibility Criteria

• Age: 52 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Completely edentulous patients
• Absence of any systematic contraindications to implant surgery,
• Presence of sufficient bone height and width to accommodate implants with length 14mmm and diameter 3.6mm.
• Inter-arch distance more than or equal 10 mm.
• Four months since the last extraction had taken place.
• No previous bone augmentation procedures.

You may not qualify if:

• psychological disorders prohibiting implant treatment.
• Heavy smoking (10 cigarettes/day)
• Alcohol and/or drug abuse,
• Physical disability that may interfere with the ability to perform oral hygiene.
• Patients were receiving drugs which impair healing .

Sponsors & Collaborators

• Amr El Sayed Khalifa: lead

Study Sites (1)

Faculty of Dentistry

Minya, Minya Governorate, 2422998, Egypt

Location

Study Officials

• Emad TB Agamy, Professor of Prosthodontics

  Faculty of Dentistry, Minia university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer of prosthodontics

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 15, 2024
• Study Start: March 15, 2022
• Primary Completion: November 30, 2023
• Study Completion: January 10, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)