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

NCT ID: NCT06637930

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2024-01-10

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. Retention of the mandibular over-denture.

2. Plaque accumulation, presence of calculus, bleeding tendency, health of peri-implant mucosa and probing depth.

II - The radiographic behavior regarding marginal bone level and bone density.

Detailed Description

This study compared implant-retained telescopic mandibular overdentures reinforced with milled metal framework (Co-Cr) and milled polymer (PEEK) in terms of retention, periimplant mucosal health, and radiographic changes in twelve patients.

Initially, all patients received conventional complete dentures. A CBCT was conducted prior to the implant surgical phase using a radiographic stent. Two implants were inserted interforaminally using a flapless method. The implants were then left for three months to allow for osseointegration, and the patients were instructed to wear their complete dentures during the healing process.

Following the osseointegration period, the prosthetic phase began, with all patients obtaining primary crowns constructed from titanium alloys. The patients were then randomly divided into two groups, 6 patients in each group. Group A received a COCR framework that included secondary crowns while group B received a PEEK framework and secondary crowns.

Retention was tested for each group (baseline, 6 months, 9 months, and 12 months) using a digital force gauge. The pulling force gradually increased until the denture was dislodged. The retentive force was measured during the initial separation of the telescopic crown.

Soft tissue conditions was assessed using single coded probe for each group (baseline, 6 months, 9 months, and 12 months).Bleeding tendency on probing, plaque accumulation, calculus deposition, perimplant mucosal health were the parameters for each group evaluation.

While the radiographic assessment was performed for each group (baseline, 6months, 9 months and12 months) using digital periapical radiographs by the means of XCP instrument and digital sensor. The marginal bone level was measured by evaluating the difference of bone level at the neck of the implant. The bone density was evaluated at three areas surrounding the implants.

Conditions

Edentulism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cobalt chromium(COCR) group

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

Group Type: EXPERIMENTAL

Edentulous Alveolar Ridge In Mandible

Intervention Type: 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

Polyetheretherketone(PEEK) Group

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

Group Type: EXPERIMENTAL

Edentulous Alveolar Ridge In Mandible

Intervention Type: 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

Interventions

Edentulous Alveolar Ridge In Mandible

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 .

• Minimum Eligible Age: 52 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amr El Sayed Khalifa

OTHER

Sponsor Role: lead

Responsible Party

Amr El Sayed Khalifa

assistant lecturer of prosthodontics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emad TB Agamy, Professor of Prosthodontics

Role: STUDY_CHAIR

Faculty of Dentistry, Minia university

Locations

Faculty of Dentistry

Minya, Minya Governorate, Egypt

Countries

Egypt

Other Identifiers

528

Identifier Type: -

Identifier Source: org_study_id