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Clinical Evaluation of Esthetic Restorations Placed in Primary Molars With Composite Resin Enriched With Insoluble Anti Bacterial Nano Particles (IABN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00389714
Recruitment Status : Unknown
Verified December 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : October 19, 2006
Last Update Posted : December 11, 2007
Information provided by:
Hadassah Medical Organization

Brief Summary:

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:

  1. To evaluate the clinical and radiographic performance of the New Restorative System when placed with adhesive systems in class II restorations of primary molars.
  2. 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.
  3. To asses, by means of polarized light microscopy, the integrity of the cervical margins of the same retrieved teeth.

Condition or disease Intervention/treatment Phase
Dental Carious Dental Filling Device: dental restoration Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00389714

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Contact: Michael Perez Davidi, DMD +972 54 3113780

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Hadassah Medical Organization
Jerusalem, Israel, 46540
Contact: Arik Zukhert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    +972543113780   
Principal Investigator: Michael Perez Davidi, DMD         
Sponsors and Collaborators
Hadassah Medical Organization
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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
Additional Information:
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.

Layout table for additonal information Identifier: NCT00389714    
Other Study ID Numbers: 191055nano HMO-CTIL
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: December 11, 2007
Last Verified: December 2007
Keywords provided by Hadassah Medical Organization:
dental restoration