Evaluation of Clinical Performance of Class IV Restoration Using Organically Modified Ceramic (OMNOCER) in Comparison to a Methacrylate Based Composite Resin

NCT05623423 | Completed

• 1 other identifier: class IV restoration
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of clinical performance of class IV restoration using organically modified ceramic (ORMOCER) in comparison to a Methacrylate Based Composite Resin: A randomized clinical trial

Conditions

Shade Match

Keywords

class IV restoration; ORMOCER; methacrylate based composite resin

Outcome Measures

Primary Outcomes (3)

• Shade match

  measured by Modified USPHS

  T1: 1 week (baseline)

• Shade match

  measured by Modified USPHS

  T2: 3 months

• Shade match

  measured by Modified USPHS

  T3: 1 year.

Secondary Outcomes (3)

• a) Retention rate

  T1: 1 week (baseline)

• a) Retention rate

  T2: 3 months

• a) Retention rate

  T3: 1 year

Study Arms (2)

Organically Modified Ceramic (ORMOCER) Resin Composite.

EXPERIMENTAL

(Admira Fusion, Voco GmbH, Germany)

Other: (Admira Fusion, Voco GmbH, Germany)

Methacrylate Based Composite

ACTIVE COMPARATOR

(Ceram.X Spectra ST, Dentsply Sirona, UK)

Other: Methacrylate Based Composite

Interventions

(Admira Fusion, Voco GmbH, Germany) OTHER

cavity margins will be extended to the proximal area, incisal edge, facial and lingual surfaces All enamel margins will be beveled at a 45° angle to the external cavosurface.(approximately 0.5-2.0 mm) An impression for the upper anterior teeth will be taken to produce a silicon palatal index The proximal margins of the restorations will be achieved using the Unica anterior matrix teeth will be etched using 37% phosphoric acid gel for 30 s then rinsed with air water for 20 s A single coat of universal bond cured using and LED light curing unit for 10 s Using the chosen enamel shade of the ORMOCER Resin Composite a thin layer (0.5-1 mm) Unica matrix will used to produce the proximal margins of the restorations Contouring, finishing and polishing of the restoration will be done Dental floss and finishing strips will be used Rubber dam will then be removed and occlusion will be checked using an articulating paper

Organically Modified Ceramic (ORMOCER) Resin Composite.

Methacrylate Based Composite OTHER

The exact same steps as in the intervention will be done but using the chosen shades of Methacrylate Based Composite Resin. (Ceram.X Spectra ST, Dentsply Sirona, UK)

Methacrylate Based Composite

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• participant:
• Age of patient (18-40) years old.
• Good oral hygiene.
• Teeth:
• Having no active pulpal or periodontal conditions.
• Normal Occlusion.
• Able to return for follow-up assessments as illustrated by the examiners. -

You may not qualify if:

• participant:
• Patients with Edge-to-Edge occlusion.
• Patients with high caries index.
• Patients with uncontrolled para-functional habits (e.g. bruxism or clenching).
• Patients with inadequate oral hygiene.
• Patients with periodontal or gingival conditions.
• Patients with orthodontic appliances.
• Patients with spontaneous pain or sensitivity to percussion
• Pregnant Patients -

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 00202, Egypt

Location

Related Publications (15)

• Barcellos DC, Batista GR, Silva MA, Pleffken PR, Rangel PM, Fernandes VV Jr, Di Nicolo R, Torres CR. Two-year clinical performance of self-etching adhesive systems in composite restorations of anterior teeth. Oper Dent. 2013 May-Jun;38(3):258-66. doi: 10.2341/11-397-C. Epub 2012 Oct 30.

  PMID: 23110580 BACKGROUND

• Blum SL, Horn M, Olms C. A comparison of intraoral spectrophotometers-Are there user-specific differences? J Esthet Restor Dent. 2018 Sep;30(5):442-448. doi: 10.1111/jerd.12407. Epub 2018 Aug 25.

  PMID: 30144376 BACKGROUND

• Cetin AR, Unlu N, Cobanoglu N. A five-year clinical evaluation of direct nanofilled and indirect composite resin restorations in posterior teeth. Oper Dent. 2013 Mar-Apr;38(2):E1-11. doi: 10.2341/12-160-C. Epub 2012 Dec 5.

  PMID: 23215545 BACKGROUND

• Demirci M, Tuncer S, Sancakli HS, Tekce N, Baydemir C. Five-year Clinical Evaluation of a Nanofilled and a Nanohybrid Composite in Class IV Cavities. Oper Dent. 2018 May/Jun;43(3):261-271. doi: 10.2341/16-358-C. Epub 2018 Mar 13.

  PMID: 29533716 BACKGROUND

• Frese C, Wohlrab T, Soliman S, Hahn B, Busch C, Babai A, Krastl G, Wolff D. A Multicenter Trial on the Long-term Performance of Direct Composite Buildups in the Anterior Dentition - Survival and Quality Outcome. J Adhes Dent. 2020;22(6):573-580. doi: 10.3290/j.jad.a45514.

  PMID: 33491402 BACKGROUND

• Gresnigt MM, Kalk W, Ozcan M. Randomized controlled split-mouth clinical trial of direct laminate veneers with two micro-hybrid resin composites. J Dent. 2012 Sep;40(9):766-75. doi: 10.1016/j.jdent.2012.05.010. Epub 2012 Jun 2.

  PMID: 22664565 BACKGROUND

• Karaman E, Yazici AR, Ozgunaltay G, Ustunkol I, Berber A. Clinical Evaluation of a Silorane- and a Methacrylate-Based Resin Composite in Class II Restorations: 24-Month Results. Oper Dent. 2017 Jul/Aug;42(4):E102-E110. doi: 10.2341/15-286-C.

  PMID: 28682704 BACKGROUND

• Llena C, Fernandez S, Forner L. Color stability of nanohybrid resin-based composites, ormocers and compomers. Clin Oral Investig. 2017 May;21(4):1071-1077. doi: 10.1007/s00784-016-1850-z. Epub 2016 May 16.

  PMID: 27183827 BACKGROUND

• Rajeev V, Arunachalam R, Nayar S, Arunima PR, Ganapathy S, Vedam V. "Ormocer an innovative technology": A replacement for conventional cements and veneer? A comparative in vitro analysis. Eur J Dent. 2017 Jan-Mar;11(1):58-63. doi: 10.4103/ejd.ejd_113_16.

  PMID: 28435367 BACKGROUND

• Ribeiro JS, Peralta SL, Salgado VE, Lund RG. In situ evaluation of color stability and hardness' decrease of resin-based composites. J Esthet Restor Dent. 2017 Sep;29(5):356-361. doi: 10.1111/jerd.12319. Epub 2017 Jul 24.

  PMID: 28737281 BACKGROUND

• Romero MF, Haddock FJ, Freites AG, Brackett WW, Brackett MG. Restorative Technique Selection in Class IV Direct Composite Restorations: A Simplified Method. Oper Dent. 2016 May-Jun;41(3):243-8. doi: 10.2341/15-158-T. Epub 2016 Feb 26.

  PMID: 26919082 BACKGROUND

• Ruschel VC, Martins MV, Bernardon JK, Maia HP. Color Match Between Composite Resin and Tooth Remnant in Class IV Restorations: A Case Series. Oper Dent. 2018 Sep/Oct;43(5):460-466. doi: 10.2341/17-132-S. Epub 2018 Mar 16.

  PMID: 29547347 BACKGROUND

• Sebold M, Lins RBE, Sahadi BO, Santi MR, Martins LRM, Giannini M. Microtensile Bond Strength, Bonding Interface Morphology, Adhesive Resin Infiltration, and Marginal Adaptation of Bulk-fill Composites Placed Using Different Adhesives. J Adhes Dent. 2021 Oct 1;23(5):409-420. doi: 10.3290/j.jad.b2000221.

  PMID: 34549924 BACKGROUND

• Torres C, Augusto MG, Mathias-Santamaria IF, Di Nicolo R, Borges AB. Pure Ormocer vs Methacrylate Composites on Posterior Teeth: A Double-blinded Randomized Clinical Trial. Oper Dent. 2020 Jul 1;45(4):359-367. doi: 10.2341/19-079-C.

  PMID: 32053457 BACKGROUND

• van Dijken JW, Pallesen U. Fracture frequency and longevity of fractured resin composite, polyacid-modified resin composite, and resin-modified glass ionomer cement class IV restorations: an up to 14 years of follow-up. Clin Oral Investig. 2010 Apr;14(2):217-22. doi: 10.1007/s00784-009-0287-z. Epub 2009 Jun 6.

  PMID: 19504133 BACKGROUND

Study Officials

• Mostafa Abdulhameed, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, data entry & corresponding author B.D.S. October University for Modern Sciences and Arts (2017). Teaching Assistant at MSA University, 6th Of October, Egypt.

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 21, 2022
• Study Start: November 30, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 4, 2024

Record last verified: 2022-12

Locations

EG (1)