Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740308
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:
This randomized clinical trial aims to compare the clinical outcomes of two full‑coronal-coverage restorations (locally-made preformed Zirconia crowns [LMP] and NuSmile Zirconia crowns [Nu/ZR]) in treating carious primary teeth. Amongst the children attending the clinics of the Dental School at Damascus University, the ones having an indication for crowns restorations will be screened and if they are conformant to the inclusion criteria then they will be recruited until 60 teeth are reached (30 teeth for LMP/ZR restorations and 30 for Nu/ZR restorations).

Condition or disease Intervention/treatment Phase
Primary Teeth Device: Locally Made Zirconia Crowns Device: ZR Zirconia Crwons NuSmile ® Crowns Not Applicable

Detailed Description:
This randomized clinical trial compares the clinical outcomes of using two full‑coronal zirconia restorations (locally-made preformed zirconia crowns, and NuSmile zirconia crowns) in treating carious primary teeth. Children attending to the clinics of the Faculty of Dentistry - Damascus University and who happen to be in need for dental restorations will be screened for the study's inclusion criteria till 60 teeth are recruited (30 teeth for locally made preformed zirconia crowns restorations and 30 for NuSmile zirconia crowns restorations). One crown only will be used for each patient (totally 60 patients) to ensure equalizing the variables for both groups. The randomization will be done using SPSS software version 20.0 (Armonk, NY; IBM Corp., USA). The study is going to be a double-blinded study (Patients blinding and Outcomes-assessor blinding). Simple descriptive statistics will be used for the analysis, also using Wilcoxon Signed-Rank test. The level of significance will be set at (α = 0.05) and the level of confidence at (95%). The intervention is preparing primary molars which have one or more indications for crowning, and according to manufacturer instructions. Then following up the treated primary molars for 1 month, 3 months, and 6 months intervals. The main goals are measuring and comparing the status of the gingiva and any improvements in the gingival health relative to the intervention, the plaque retention in regard to the gingival response to the material of restoration, and also the crowns resistance to changes, despite its high cost.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double-blinded study (Patients blinding & Outcome-assessor blinding).
Primary Purpose: Treatment
Official Title: Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth
Actual Study Start Date : May 17, 2018
Actual Primary Completion Date : December 1, 2018
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Active Comparator: Locally Made Zirconia Crowns
One operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions.
Device: Locally Made Zirconia Crowns
Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. Locally Made Zirconia Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).

Experimental: ZR Zirconia Crwons NuSmile ® Crowns
One operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions. (Same as Arm 1 Description)
Device: ZR Zirconia Crwons NuSmile ® Crowns
Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. ZR Zirconia Crwons NuSmile ® Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).




Primary Outcome Measures :
  1. Changes of crowns integrity [ Time Frame: Evaluating after 1 month, 3 months, 6 months ]
    Crowns integrity changes will be measured with the naked eye and the light cure device. The scores are as follows: (0 = No crack, No fracture, No chip) (1 = Chip) (2 = Crack) (3 = Fracture). (Cvar and Rygp 2005)


Secondary Outcome Measures :
  1. Changes of gingival index [ Time Frame: Evaluating after 1 month, 3 months, 6 months ]
    is measured by passing the periodontal probe tip gently within the sulcus around each crowned tooth. The scores are as follows: (0 = normal gingiva) (1= mild inflammation) (2 = Moderate inflammation) (3 = severe inflammation). (Loe and Silness 1963)

  2. Changes of crown marginal adaptation [ Time Frame: Evaluating after 1 month, 3 months, 6 months ]
    Crown marginal adaptation will be measured at the buccal and lingual walls and will be referred to as either good for crowns with sealed margins or poor when the explorer detects an open margin. (Farsi and Sharaf 2004)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients within the age group of 4 to 8 years of age.
  • Patients with good oral hygiene.
  • Healthy children, i.e. free of any systematic diseases or any developmental disturbances of the teeth and jaws
  • A minimal of two surfaces of caries in the targeted tooth
  • Corresponding treated teeth has not got any crown earlier
  • Patients with ECC as defined by the American Academy for Pediatric Dentistry.
  • Cooperative patients who have a dental behavioral assessment of "definitely positive" according to Frankl behavior classification scale.

Exclusion Criteria:

  • No patient is excluded by gender, race, or due to socio-economic backgrounds.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740308


Contacts
Layout table for location contacts
Contact: Louay M Hanafi, MSc. Student +963942248796 Louay.ha.91@gmail.com
Contact: Mohamed AlTinawi, PhD. +963955358197 Mohamedaltinawi@gmail.com

Locations
Layout table for location information
Syrian Arab Republic
Damascus University Recruiting
Damascus, Syrian Arab Republic, 00963
Contact: Ahmad S Burhan, PhD    00963944302075    dr.burhan-a@hotmail.com   
Sponsors and Collaborators
Damascus University
Investigators
Layout table for investigator information
Study Director: Mohamed AlTinawi, PhD. Professor - Pediatric Dentistry Department - Faculty of Dentistry - Damascus University

Publications of Results:
Layout table for additonal information
Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03740308     History of Changes
Other Study ID Numbers: UDDS-Pedo-01-2018
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The Individual participant data will be only available for the researchers in the department of Pedodontics, Damascus University

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Damascus University:
Primary posterior teeth
zirconia crown

Additional relevant MeSH terms:
Layout table for MeSH terms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action