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Clinical Trials/NCT06496828
NCT06496828
Recruiting
Not Applicable

Clinical Performance of All-Ceramic Crowns on Teeth Prepared With Biologically Oriented Preparation Technique Compared to Horizontal Preparation

Damascus University1 site in 1 country60 target enrollmentApril 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Crowns
Sponsor
Damascus University
Enrollment
60
Locations
1
Primary Endpoint
Change in the gingival index
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

This study aims to evaluate the periodontal response of teeth prepared with a biologically oriented preparation technique (BOPT) compared to conventional preparation for all-ceramic crowns.

Detailed Description

The study aims to evaluate the clinical performance of all-ceramic crowns on teeth prepared with two different types of preparations. This randomized controlled trial will include 60 teeth divided into two groups: 30 teeth will be prepared with BOPT, and 30 teeth will be prepared with shoulder margins. All teeth will receive monolithic or bi-layered ceramic crowns. Patients are planned to attend follow-up visits after 3, 6, 12, and 18 months, respectively, after cementation. Probing depth, gingival recession, bleeding on probing, gingival index, gingival thickness, patient opinion, and mechanical and biological complications are all recorded at check-up appointments.

Registry
clinicaltrials.gov
Start Date
April 30, 2024
End Date
December 30, 2027
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients older than
  • Two teeth at least needed to be restored with full crowns (each patient needs at least two single crowns).
  • Stable occlusion.
  • Good oral hygiene.
  • Periodontally healthy teeth.
  • Nonsmoking or smoking less than ten cigarettes/day.
  • Probing depth between 1 and 3 mm.

Exclusion Criteria

  • Patients younger than
  • Parafunctional habits.
  • Active periodontal disease.
  • Poor oral hygiene.
  • Systemic disease that may affect the periodontal health.
  • Pregnancy.
  • Radiation or chemotherapy.
  • Treatment by Bisphosphonates medication.
  • Patients who are unable or unwilling to attend follow-up visits

Outcomes

Primary Outcomes

Change in the gingival index

Time Frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

The gingival index will be measured at the buccal, lingual, mesial, and distal sites of each included tooth according to Silness and Löe, 1964

Change in the gingival marginal stability

Time Frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

The gingival marginal stability at the buccal site will be measured using a UNC periodontal probe and a transparent jig to measure the distance between a reference point on the jig and the free gingival margin.

Change in the Plaque index

Time Frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

The plaque index will be measured at the buccal, lingual, mesial, and distal sites of each included tooth, according to Löe and Silness, 1963

Change in the free gingiva thickness

Time Frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

The free gingiva thickness will be measured at the buccal site using a transparent jig with a reference point on the marginal gingiva, a 15-size spreader with a rubber stopper, and a millimetric ruler

Change in the probing depth

Time Frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

A UNC periodontal probe will be used to measure the probing depth at the buccal, lingual, mesial, and distal sites of each included tooth.

Change in bleeding on probing

Time Frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

This variable will be measured at the buccal, lingual, mesial, and distal sites of each included tooth, recorded simultaneously with probing depth, according to Ainamo and Bay, 1975

Secondary Outcomes

  • Change in the internal and marginal adaptation(Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.)
  • Change in the functional and mechanical complications(Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.)
  • Change in the secondary caries status(Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.)
  • Change in the color matching(Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.)
  • Change in the marginal adaptation after crown cementation(Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.)
  • Change in the clinical success(Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.)
  • Change in patients' satisfaction(This will be measured at one week and 18 months following cementation.)

Study Sites (1)

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