Clinical Evaluation of Esthetic Restorations Placed in Primary Molars With Composite Resin Enriched With Insoluble Anti Bacterial Nano Particles (IABN)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Hadassah Medical Organization.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00389714
First received: October 18, 2006
Last updated: December 10, 2007
Last verified: December 2007
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Purpose
Composite resins are presently among the most popular esthetic restorative materials in dentistry. These materials offer excellent esthetic appearance, allow for conservative cavity preparation and are now becoming widely accepted for clinical use in primary molars 1-23. Despite the improvement of their properties, achieved with better materials and incremental placing techniques, composite resin restorations appear to have still several drawbacks: although similar to amalgam in short terms studies, they have a high long term failure rate, mainly due to discoloration, loss of retention and secondary caries3,11,19, are time-consuming and technique sensitive, lack anti-cariogenic potential and can be amenable to secondary caries at the cervical dentin margins 1, 2.
Continued interest in providing advance in restorative esthetic materials led to the development of new generations of composites. Among the newest material developed is the use of minute amount of nanoparticles which convert composites to possess permanent antibacterial properties.
It is of great interest to observe the clinical behavior of this new material when utilized in clinical practice. Thus the aims of the present in-vivo study are:
- To evaluate the clinical and radiographic performance of the New Restorative System when placed with adhesive systems in class II restorations of primary molars.
- To assess, by SEM, the micromorphology of the cervical, buccal and lingual margins of the proximal surfaces of the restored teeth retrieved after exfoliation or extraction.
- To asses, by means of polarized light microscopy, the integrity of the cervical margins of the same retrieved teeth.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Carious Dental Filling |
Device: dental restoration |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Phase 2 Clinical Study :Evaluation of the Efficacy of Insoluble Antibacterial Nanoparticles Incorporated Into Commercialy Used Composit Resins as an Esthetic Restoration Material in Children |
Resource links provided by NLM:
Further study details as provided by Hadassah Medical Organization:
Eligibility| Ages Eligible for Study: | 5 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- To be eligible to participate in the study the children will have to be between 5 to 10 years old, and present at least two primary molars with a small to moderate proximal carious lesion. These should be in proximal contact with an adjacent tooth and with an antagonist. The children will have to be available for recall appointments every six months until exfoliation of the teeth, and have parental consent to participate in this study.
Exclusion Criteria:
- systemic disorders.
- chemotherapy in the last five years
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389714
Contacts
| Contact: Michael Perez Davidi, DMD | +972 54 3113780 | michaelpd@hadassah.org.il |
Locations
| Israel | |
| Hadassah Medical Organization | Not yet recruiting |
| Jerusalem, Israel, 46540 | |
| Contact: Arik Zukhert, DMD 00 972 2 6776095 arik@hadassah.org.il | |
| Contact: Hadas Lemberg, PhD +972543113780 perezdavidi@bezeqint.net | |
| Principal Investigator: Michael Perez Davidi, DMD | |
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
| Study Director: | Michael Perez Davidi, DMD | Hadassah Medical Organization |
| Study Chair: | Ana Fux, DMD | Hadassah Medical Organization |
| Study Director: | Mordechay Moskovitch, DMD | Hadssah Medical Orgenization |
More Information
Additional Information:
Publications:
I -Tonn B and Ryge G: Clinical evaluation of composite resin restorations in primary molars: a 4-year follow-up study. JADA 117:603-606, 1988. 2 -Letzel H: Survival rates and reasons for failure of posterior composite restorations in multicenter clinical trial. JDent 17:S10-S17, 1988. 3- Fuks AB, Araujo FB, Osorio LB, Hadani PE, Pinto AS. Clinical and radiographic assessment of Class II esthetic restorations in primary molars. Pediatr Dent. 2000 Nov-Dec;22(6):479-85. 4 -Yap AU, Chew CL, Ong LF, Teoh SH: Environmental damage and occlusal contact area wear of composite restoratives. J Oral Rehabil. 29:87-97, 2002. 5 -Yap AU, Tan SH, Wee SS, Lee CW, Lim EL, Zeng KY: Chemical degradation of composite restoratives. J Oral Rehabil. 28:1015-21, 2001. 6 -Baratieri LN, Ritter AV: Four-year clinical evaluation of posterior resin-based composite restorations placed using the total-etch technique. J Esthet Restor Dent. 13:50-7, 2001. 7 -Attin T, Opatowski A, Meyer C, Zingg-Meyer B, Buchalla W, Monting JS: Three-year follow up assessment of Class II restorations in primary molars with a polyacid modified composite resin and a hybrid composite. Am J Dent. 14:148-52, 2001. 8 -Kohler B, Rasmusson CG, Odman P. A five-year clinical evaluation of Class II composite resin restorations. J Dent. 28:111-6, 2000. 9 -Pesun IJ, Olson AK, Hodges JS, Anderson GC: In vivo evaluation of the surface of posterior resin composite restorations: a pilot study. J Prosthet Dent. 84:353-9, 2000. 10 -Wang NJ: Is amalgam in child dental care on its way out? Restorative materials used in children and adolescents in 1978 and 1995 in Norway. Community Dent Health. 17:97-101, 2000. 11 -Duncalf WV, Wilson NH: A comparison of the marginal and internal adaptation of amalgam and resin composite restorations in small to moderate-sized Class II preparations of conventional design. Quintessence Int. 31:347-52,2000. 12 -Feigal RJ: Advantages of new restorative materials in dental care for children. J Mich Dent Assoc. 81:32-6, 38, 1999. 13 -Berg JH: The continuum of restorative materials in pediatric dentistry--a review for the clinician. Pediatr Dent. 20:93-100, 1998. 14 -McWhorter AG, Seale NS: For a limited time only! Or treatment of temporary teeth in tots. Tex Dent J. 114:21-6, 1997. 15 -Christensen GJ: Restoration of pediatric posterior teeth. J Am Dent Assoc.127:106-8, 1996. 16 -Croll TP: Restorative dentistry for preschool children. Dent Clin North Am.39:737-70, 1995. 17 -Granath L, Schroder U, Sundin B: Clinical evaluation of preventive and class-I composite resin restorations. Acta Odontol Scand. 1992 Dec; 50(6): 359-64. 18 -Ostlund J, Moller K, Koch G: Amalgam, composite resin and glass ionomer cement in Class II restorations in primary molars--a three year clinical evaluation. Swed Dent J. 16:81-6, 1992. 19 -Barr-Agholme M, Oden A, Dahllof G, Modeer T: A two-year clinical study of light-cured composite and amalgam restorations in primary molars. Dent Mater. 7:230-3, 1991. 20 -Dietschi D, Holz J: A clinical trial of four light-curing posterior composite resins: two-year report. Quintessence Int. 21:965-75, 1990. 21 -Vann WF Jr, Barkmeier WW, Mahler DB: Assessing composite resin wear in primary molars: four-year findings. J Dent Res. 67:876-9,1988. 22 -Leifler E, Varpio M: Proximoclusal composite restorations in primary molars: a two-year follow-up. ASDC J Dent Child. 48:411-6, 1981. 23 -Tonn EM, Ryge G, Chambers DW: A two-year clinical study of a carvable composite resin used as class II restorations in primary molars. ASDC J Dent Child. 47:405-13, 1980 24- Tinanoff N, Douglas JN: Clinical decision -making for caries management in primary teeth. J Dent Edu 65:1133-1142, 2001. 25- Cvar JF and Ryge G: Criteria for the clinical evaluation of dental restorative .materials. USPHS Publication n.790 p244, San Francisco: US Government Printing Office. 26 -Fuks AB, Holan G, Simon H and Levinstein I: Microleakage of class II glass- ionomer-silver restorations in primary molars. Operative Dent 17:62-69, 1992. 27- Fuks AB, Araujo FB, Donly KJ, Cervantes M: Reliability of Different Techniques to Assess Marginal Defects of Class II Restorations in Retrieved Primary Molars: a visual-tactile, SEM, dye penetration and polarized light microscopy study. The Journal of the Israel Dental Association 19:6-16, 2002.
| ClinicalTrials.gov Identifier: | NCT00389714 History of Changes |
| Other Study ID Numbers: | 191055nano HMO-CTIL |
| Study First Received: | October 18, 2006 |
| Last Updated: | December 10, 2007 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Hadassah Medical Organization:
|
pedodontics carious dental restoration antibacterial nanoparticles |
Additional relevant MeSH terms:
|
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013