Gingival Inflammatory Response,Bacterial Adhesion and Patient Satisfaction of Ceramo-metallic vs Zirconia Crowns

NCT04077606 | Unknown DMC

• 1 other identifier: CairoUniversity
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ceramo metallic restoration has proved high success rate over past years as considered to be the gold standard while Monolithic zirconia as fixed dental prostheses have gained attention because of their good fracture strength, low wear of the enamel antagonist and pleasant color .Material composition will affect gingival health and biofilm formation which initiate caries and periodontal diseases.

Conditions

Gingival Inflammation; Oral Bacterial Infection

Keywords

interleukin 1 beta, bacterial adhesion,monolithic zirconia

Outcome Measures

Primary Outcomes (1)

• Gingival inflammatory response

  presence and concentration of interleukin 1 -beta

  12 weeks

Secondary Outcomes (1)

• bacterial adhesion

  12 weeks

Other Outcomes (1)

• patient satisfaction

  12 weeks

Study Arms (2)

ceramo-metallic crown

ACTIVE COMPARATOR

ceramo-metallic crown preparation

Other: ceramo-metallic crown prepartion; Other: full anatomical monolithic zirconia crown

monolithic zirconia crown

ACTIVE COMPARATOR

monolithic zirconia crown preparation

Other: ceramo-metallic crown prepartion; Other: full anatomical monolithic zirconia crown

Interventions

ceramo-metallic crown prepartion OTHER

tooth will be prepared to receive ceramo-metallic crowns

Also known as: feldspathic porcelain fused to metal

ceramo-metallic crown; monolithic zirconia crown

full anatomical monolithic zirconia crown OTHER

tooth will be prepared to receive monolithic zirconia crowns

Also known as: katana zirconia, Kuraray Noritake , Japan

ceramo-metallic crown; monolithic zirconia crown

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age range from 20-50 to be able to read and write in order to sign the informed consent document.
• Patients physically and psychologically able to tolerate conventional restorative procedures.
• Patients with no active periodontal and or pulpal diseases, having teeth with good restorations.
• Patients with root canal treated teeth requiring full coverage restorations.
• Patients indicated for full coverage (e.g. moderate to severe discoloration, coronal fracture).
• Patients didn't take antibiotics or anti-inflammatory in the past three months.
• Surfaces with an adjacent probing pocket depth exceeding 3mm were not included
• Patients willing to return for follow-up examinations and assessments.

You may not qualify if:

• Patients in the growth stage with partially erupted teeth.
• Patient with poor oral hygiene.
• Patients with psychiatric problems or unrealistic expectations
• Patient with no opposite occluding dentition in the area intended for restoration.
• Patient suffering from Para functional habits.
• Patient with diabetes mellitus, hypertension and gingivitis or periodontitis which has impact on gingival cervicular fluid level

Sponsors & Collaborators

• Cairo University: lead

Related Publications (15)

• Griggs JA. Recent advances in materials for all-ceramic restorations. Dent Clin North Am. 2007 Jul;51(3):713-27, viii. doi: 10.1016/j.cden.2007.04.006.

  PMID: 17586152 BACKGROUND

• Lekesiz H. Reliability estimation for single-unit ceramic crown restorations. J Dent Res. 2014 Sep;93(9):923-8. doi: 10.1177/0022034514544215. Epub 2014 Jul 21.

  PMID: 25048249 BACKGROUND

• Sailer I, Makarov NA, Thoma DS, Zwahlen M, Pjetursson BE. All-ceramic or metal-ceramic tooth-supported fixed dental prostheses (FDPs)? A systematic review of the survival and complication rates. Part I: Single crowns (SCs). Dent Mater. 2015 Jun;31(6):603-23. doi: 10.1016/j.dental.2015.02.011. Epub 2015 Apr 2.

  PMID: 25842099 BACKGROUND

• Hobo S, Shillingburg HT Jr. Porcelain fused to metal: tooth preparation and coping design. J Prosthet Dent. 1973 Jul;30(1):28-36. doi: 10.1016/0022-3913(73)90075-9. No abstract available.

  PMID: 4575207 BACKGROUND

• Sun T, Zhou S, Lai R, Liu R, Ma S, Zhou Z, Longquan S. Load-bearing capacity and the recommended thickness of dental monolithic zirconia single crowns. J Mech Behav Biomed Mater. 2014 Jul;35:93-101. doi: 10.1016/j.jmbbm.2014.03.014. Epub 2014 Apr 2.

  PMID: 24762856 BACKGROUND

• Baladhandayutham B, Lawson NC, Burgess JO. Fracture load of ceramic restorations after fatigue loading. J Prosthet Dent. 2015 Aug;114(2):266-71. doi: 10.1016/j.prosdent.2015.03.006. Epub 2015 May 16.

  PMID: 25985741 BACKGROUND

• Piconi C, Maccauro G. Zirconia as a ceramic biomaterial. Biomaterials. 1999 Jan;20(1):1-25. doi: 10.1016/s0142-9612(98)00010-6.

  PMID: 9916767 BACKGROUND

• Chen YM, Smales RJ, Yip KH, Sung WJ. Translucency and biaxial flexural strength of four ceramic core materials. Dent Mater. 2008 Nov;24(11):1506-11. doi: 10.1016/j.dental.2008.03.010. Epub 2008 Apr 25.

  PMID: 18440062 BACKGROUND

• Beuer F, Schweiger J, Eichberger M, Kappert HF, Gernet W, Edelhoff D. High-strength CAD/CAM-fabricated veneering material sintered to zirconia copings--a new fabrication mode for all-ceramic restorations. Dent Mater. 2009 Jan;25(1):121-8. doi: 10.1016/j.dental.2008.04.019. Epub 2008 Jul 11.

  PMID: 18620748 BACKGROUND

• Goldberg PV, Higginbottom FL, Wilson TG. Periodontal considerations in restorative and implant therapy. Periodontol 2000. 2001;25:100-9. doi: 10.1034/j.1600-0757.2001.22250108.x.

  PMID: 11155185 BACKGROUND

• Gunay H, Seeger A, Tschernitschek H, Geurtsen W. Placement of the preparation line and periodontal health--a prospective 2-year clinical study. Int J Periodontics Restorative Dent. 2000 Apr;20(2):171-81.

  PMID: 11203559 BACKGROUND

• Lang NP, Berglundh T, Heitz-Mayfield LJ, Pjetursson BE, Salvi GE, Sanz M. Consensus statements and recommended clinical procedures regarding implant survival and complications. Int J Oral Maxillofac Implants. 2004;19 Suppl:150-4. No abstract available.

  PMID: 15635955 BACKGROUND

• Zenthofer A, Ohlmann B, Rammelsberg P, Bomicke W. Performance of zirconia ceramic cantilever fixed dental prostheses: 3-year results from a prospective, randomized, controlled pilot study. J Prosthet Dent. 2015 Jul;114(1):34-9. doi: 10.1016/j.prosdent.2015.02.006. Epub 2015 Apr 14.

  PMID: 25882973 BACKGROUND

• Kato A, Imai K, Ochiai K, Ogata Y. Prevalence and quantitative analysis of Epstein-Barr virus DNA and Porphyromonas gingivalis associated with Japanese chronic periodontitis patients. Clin Oral Investig. 2015 Sep;19(7):1605-10. doi: 10.1007/s00784-014-1387-y. Epub 2014 Dec 18.

  PMID: 25515271 BACKGROUND

• Reddy MS. The use of periodontal probes and radiographs in clinical trials of diagnostic tests. Ann Periodontol. 1997 Mar;2(1):113-22. doi: 10.1902/annals.1997.2.1.113.

  PMID: 9151548 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind (trial participants and outcome assessors). Each participant included in this study will be blinded (without knowing type of intervention received). Blinded assessors :blinding to the laboratory assessors is done by not involving them in sequence generation or allocation concealment or treatment options.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nashwa hefnawy

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: September 4, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: September 4, 2019

Record last verified: 2019-08