Posterior Implant-Supported Modified Monolithic Zirconia and Metal-Ceramic Single Crowns: 5 Years Study

NCT04355325 | Unknown DMC

• 1 other identifier: Jordan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The outcome of implant therapy has been presented in the majority of clinical studies by focusing only on implant survival without providing detailed information on the reconstructions . However, for decision making, it is important to know the survival rates and the incidence of biological and technical complications not only for the implants but also for the reconstructions. Thus, the selection of restoration materials should be based on proper optical characteristics in addition to biocompatibility and sufficient strength of materials. Monolithic zirconia has been used in posterior region, especially for single crowns, in order to eliminate the veneer cracking, But Since monolithic zirconia are relatively new, few randomized, controlled clinical studies have evaluated their success. There is only one study identified regarding the performance of monolithic ceramic restorations bonded to Ti inserts, investigating the clinical outcome of using monolithic or modified monolithic zirconia implant-supported single crowns and comparing outcomes and complications of metal-ceramic and monolithic or modified monolithic zirconia implant supported single crowns. More clinical studies to evaluate the performance of CAD/CAM monolithic implant-supported restorations bonded to Ti inserts and bases and compare their survival, success and complication rates with other restorative options \[with a mean follow-up period of at least 5 years are required for a meaningful interpretation of the survival and complication rate . So this study aims to investigate outcomes and complications of implant supported modified monolithic zirconia and metal-ceramic single crowns in the posterior region of the mouth. The null hypothesis is that there is no difference between modified monolithic zirconia and metal-ceramic posterior implant-supported SCs in prosthetic complication rates.

Conditions

Posterior Occlusion; Fracture

Keywords

Implant; Zirconia; crown; molar

Outcome Measures

Primary Outcomes (5)

• Screw loosing

  Alpha rating: no screw loosening Bravo rating: loose screw that can be retightened Delta rating: fractured screw that needs replacement

  5 years

• Marginal integrity

  Visual inspection with dental explorer to the abutment-restoration interphase under fourfold to fivefold optical magnification. Digital bitewing radiographs with standardized paralleling technique using Ring holders and analogue films will be taken at baseline then at each recall visit and compared together for any misfits or gaps. Alpha rating: no visible or soundable gap Bravo rating: marginal gap slightly soundable Charlie rating: explorer penetrates a significant crevice Delta rating: restoration needs to be replaced

  5 years

• chipping of veneering ceramic

  Visual and tactile inspection of the restorations will be made to check for any chippings of the restoration. Fourfold to fivefold optical magnification will be used. Clinical photographs will be taken for crowns and neighboring teeth at delivery stage. Impressions will be made as well and poured into stone. New impressions will be made at each recall visit, poured into stone, then stone casts will be evaluated using a light microscope and compared with surface topography of casts made at prosthetic delivery stage to detect any potential minor chip-off fractures. * Alpha rating: No fracture * Bravo rating: minor chipping (polishable) * Charlie rating: major chipping (up to framework) * Delta rating: restoration needs to be replaced If chipping rating changes during the observation period, the most severe rating will be recorded

  5 years

• occlusal roughness

  Crowns will be dried at each recall visit and visually inspected under fourfold to fivefold optical magnification for any roughness. Alpha rating: no roughness Bravo rating: slight roughness (\< 2mm) Charlie rating: obvious roughness (\> 2mm) Delta rating: restoration needs to be replaced If roughness rating changes during the observation period, the most severe rating will be recorded

  5 years

• framework fracture

  Visual and tactile inspection of the restorations will be made to check for fracture or loss of the restoration. Fourfold to fivefold optical magnification will be used. Clinical photographs will be also taken for crowns and neighboring teeth at delivery stage then at each recall visit and compared together. * Alpha rating: No fracture * Delta rating: restoration needs to be replaced If fracture rating changes during the observation period, the most severe rating will be recorded.

  5 years

Secondary Outcomes (2)

• Marginal bone loss:

  1 year

• Crown de-bonding

  5 years

Study Arms (2)

Experimental

ACTIVE COMPARATOR

modified monolithic zirconia crowns At the time of the second optical impression, implants will be randomly allocated to either the test group (modified monolithic zirconia crowns) or the control group (metal ceramic crowns), using a computer-generated randomization list.

Device: modified monolithic zirconia crowns; Device: Metal Ceramic crowns

control

PLACEBO COMPARATOR

metal ceramic crowns At the time of the second optical impression, implants will be randomly allocated to either the test group (modified monolithic zirconia crowns) or the control group (metal ceramic crowns), using a computer-generated randomization list.

Device: modified monolithic zirconia crowns; Device: Metal Ceramic crowns

Interventions

modified monolithic zirconia crowns DEVICE

outcomes and complications of implant restoration

Also known as: Zirconia

Experimental; control

Metal Ceramic crowns DEVICE

outcomes and complications of implant restoration

Also known as: Metal-Ceramic

Experimental; control

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 21 to 55 years, with no contraindications to dental treatment.
• Need implant supported single crown in the maxillary and/or mandibular premolar and/or molar area
• No systemic disease.
• No signs of bruxism.
• Full-mouth plaque scores and full-mouth bleeding scores of \<25%
• Good overall dental health, no active caries, no active periodontal disease, and periodontal pocket depths not greater than 4 mm.
• Adequate bone height and width at areas of proposed implant sites
• Adequate interocclusal distance to accommodate the prosthesis
• Space width with mesial -distal width of at least 6 mm.
• Good oral hygiene and compliance with oral hygiene instructions as determined by the amount of plaque present on tooth surfaces
• Thick or medium gingival biotype.
• Bilateral one missing tooth being a premolar or molar in the maxilla or mandible with adjacent natural teeth.
• Fixed teeth opposing the edentulous area and a full complement of teeth or restored teeth in all other areas.

You may not qualify if:

• Systemic disease
• Pregnant and lactating women
• Unwilling to receive radiographs
• Presence of clinically active periodontal disease as expressed by probing pocket depths 4 mm in combination with bleeding on probing
• Presence of peri-apical lesions or any other abnormalities in the region as detected on a radiograph.
• Subjects that get diagnosed with any systemic disease, start smoking, or become pregnant during the study period will be excluded from the study

Sponsors & Collaborators

• Jordan University of Science and Technology: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, 21110, Jordan

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Rola Alhabshneh, Prof

  JUST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rola Alhabshneh, Prof

CONTACT

+962796064813; raalhabashneh@just.edu.jo

esam Alem, Prosthetic

CONTACT

ealem@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Rola Alhabashneh

Model Details: This single-blind split mouth study will enroll 60 participants, having to receive 120 dental Implants. They will be recruited from 3 dental centers in Jordan .

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: April 21, 2020
• Study Start: April 2, 2020
• Primary Completion: May 2, 2024
• Study Completion: December 5, 2024
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)