Clinical and Radiographical Evaluation of CAD-CAM Crowns With and Without Deep Margin Elevation

Clinical and Radiographical Evaluation of CAD-CAM Crowns With and Without Deep Margin Elevation: Up to 10-year Results

Deep margin elevation (DME) is a non-invasive restorative technique to relocate the deep cervical margin to a supragingival position using resin composite. This retrospective multicenter practice-based study will assess the long-term clinical performance and periodontal health of teeth restored with CAD-CAM crowns with or without DME. Patients who will receive CAD-CAM lithium disilicate (LD) crowns with or without DME between 2013 and 2023 at multiple private practices will be included. When indicated, DME will be performed using resin-based restoration. Clinical assessment of the crowns and supporting periodontal structures will be performed following the modified United States Public Health Service (USPHS) criteria. Intra-oral photographs, periapical and bitewing radiographs will be taken for further assessment by three evaluators. Kaplan Meier survival analyses will be performed.

Study Overview

• Status: Recruiting
• Conditions: Caries,Dental; Survival, Prosthesis; Failure, Prosthesis; Broken Teeth; Crown of Tooth With Poor Contour
• Intervention / Treatment: Procedure: Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crowns

Detailed Description

The ethical approval to conduct this retrospective multicenter practice-based study was obtained from the Research Ethics Committee at the University of Sharjah (REC-23-09-11-01-F). The present report will complie with the STROBE guidelines for cohort studies.

Participants selection Patient records at 7 private practices in the UAE will be searched for the presence of posterior LD CAD-CAM crowns during 2013 to 2016. Inclusion criteria: adult patient and indication for crown with or without DME. Exclusion criteria: poor oral hygiene and active periodontal disease. A total of 560 eligible patients will be invited to a clinical examination.

Clinical Examination The clinical evaluation will be conducted by three calibrated independent prosthodontists. Patients will be requested to read and sign an informed consent form to participate in the study. Intraoral photographs, Periapical and bitewing radiographs will be obtained to assess the emergence profile of the DEM which should ideally reproduce the normal morphology. Both the crowned tooth and the contralateral tooth were assessed clinically for the following parameters: pocket depth (PD), BoP, and presence of plaque using a plaque indicator liquid (Mira-2 Ton Liquid, Hager & Werken; Duisburg, Germany). Bone level will be assessed by comparing a measurement from the margin of the tooth to the crest of the bone on bitewing radiographs to corresponding preoperative radiographs.

A comprehensive assessment of the restored teeth will be carried out following the modified United States Public Health Service (USPHS) criteria. The location of crown margin will be recorded clinically and radiographically to assess the association between periodontal health and margin location. The primary outcomes will be the survival rate and time to event. The secondary outcome will be the success rate. The success is defined as a crown that had remained unchanged over the observation period, while survival is defined as a crown that was in situ at the examination visit but might exhibits chipping or have been repaired. Failure will be scored for the followings: recurrent caries, loss of vitality, tooth fracture, and crown fracture.

Statistical analysis Descriptive statistics were computed with a statistical software program (IBM SPSS Statistics, v29; IBM Corp., Armonk, NY, USA). Each complication will be considered as a statistical event. The statistical testing will be 2-tailed (a=.05). The McNemar chi-squared and Fisher exact tests will be used to assess the severity of PD, BoP and plaque deposition. Odds ratios and their 95% confidence intervals will be reported. The Pearson chi-squared test for differences in proportions will be used to assess the relationship between the location of margins and the associated condition of the periodontal tissues. Kaplan-Meier survival analysis will be performed to calculate the overall crown survival and success probabilities. Cox regression models will be used to evaluate the effect of various confounding factors on the survival and success rates.

• Study Type: Interventional
• Enrollment (Estimated): 560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Aziz, PhD; Phone Number: +97165057312; Email: a.aziz@sharjah.ac.ae
• Study Contact Backup: Name: Sama Suliman, MS; Phone Number: +9715057370; Email: s.suliman@sharjah.ac.ae

Study Locations

• United Arab Emirates
  • Sharjah, United Arab Emirates, 7724
    • Recruiting
    • University of Sharjah
    • Contact: Sharjah registerar, registerar; Email: registerar@sharjah.ac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: :

• adult patient and indication for crown with or without DME.

Exclusion Criteria:

• poor oral hygiene and active periodontal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Deep margin elevation followed by crowns; Teeth restored with DME and crowns

Procedure: Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crowns; Restoration of the deep margin by composite restorations such as: Filtek Supreme XTE, Tetric EvoCeram, Estelite Sigma Qquick followed by Lithium disilicate glass-ceramic CAD/CAM crowns (IPS e.max CAD).; Other Names: Filtek Supreme XTE (3M ESPE, Seefeld, Germany); Tetric EvoCeram (Ivoclar Vivadent AG, Schaan, Lichtenstein); Estelite Sigma Qquick (Tokuyama, Tokyo, Japan); IPS e.max CAD (Ivoclar Vivadent AG, Schaan, Lichtenstein)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The survival rate of teeth restored with or without DME and crowns.	Number of survived crowns in the presence or absence of DME	10 years
Number of failed crowns in the presence or absence of DME		10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pocket depth		10 years
Change from baseline in bleeding of probing		10 years
Periodontal responses in response to deep (subgingival) margins	Change from baseline in bone level cervically	10 years

Collaborators and Investigators

• Sponsor: University of Sharjah
• Investigators: Principal Investigator: Ahmed M Aziz, PhD, University of Sharjah

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Prosthesis Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: 50571100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No