Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment

NCT02071953 | Completed Results

• 2 other identifiers: 765-550815642
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (8)

• Color Match

  The color match will be assessed clinically according to Ryge (1973)\* for matching with adjacent teeth and stability of color matching over time. Assessments will be done to the following criteria: Alpha= Restoration matches adjacent tooth structure in shade and/or translucency. Bravo= Mismatch in shade and/or translucency is within normal range of tooth shades. Charlie= Mismatch in shade and/or translucency is outside normal range of tooth shades. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.

  Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.

• Marginal Discoloration

  Marginal discoloration will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: Alpha= No visual evidence of marginal discoloration. Bravo= Marginal discoloration present but has not penetrated in a pulpal direction. Charlie= Marginal discoloration has penetrated in a pulpal direction. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.

  Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.

• Marginal Integrity

  Change in marginal integrity will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: A= Explorer does not catch or slight catch with no visible crevice. B= Explorer catches and crevice is visible but no exposure of dentin or base. C= Explorer penetrates crevice and defect extended to amelo-dentinal junction. D= Restoration is fractured, mobile, or missing in part or in toto. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.

  Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.

• Presence of Secondary Dental Caries (Cavities)

  Change in presence of secondary dental caries will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: A= No caries present. D= Caries present associated with the restoration. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. Note: Secondary caries is a categorical, dichotomous variable, i.e. there is caries or not. This was assessed clinically and radiographically by a trained professional (dentist).

  Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.

• Presence of Restoration Fractures (Localized or Bulk)

  The restoration will be assessed clinically according to Ryge (1973)\* for presence of fractures over time. Assessments will be done to the following criteria: A= Smooth restoration surface with no irregularities. B= Slightly rough or pitted restoration surface. Can be refinished. C= Deeply pitted or grooved (not related to anatomy) restoration finish. Can not be refinished. D= Restoration surface is fractured or flaking. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.

  Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.

• Post-operative Sensitivity

  Patient will be interviewed to assess post-operative sensitivity according to the following criteria: A= No sensitivity. B= Mild sensitivity. C= Moderate sensitivity with no restoration replacement required. D= Sever sensitivity. Replacement of restoration is required. Tooth sensitivity will be assessed at baseline and each follow-up appointment using cold thermal test (Endo-Ice, Hygienic) and Electric Pulp Test (EPT) when indicated.

  Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.

• Surface Condition of Restoration

  The change in surface condition of restoration will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: A= Restoration is continuous with existing anatomic form. B= Restoration is discontinuous with existing anatomic form but missing material is not sufficient to expose dentin or lining. C= Sufficient restorative material is lost to expose dentin. \*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.

  Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.

• Gingival Inflammation Index

  Patient's gingiva will be assessed clinically according to Ryge (1973)\* over time. Assessments will be done to the following criteria: 0 = Normal gingiva. 1. = Mild inflammation, slight change in color, slight edema, no bleeding upon probing. 2. = Moderate inflammation, redness; edema and glazing; bleeding upon palpation. 3. = Severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding. * As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. Note: At 6 months data was not reported. At Baseline, all patients presented a score of 0. Any patient with a score greater than zero would have been excluded at baseline. Patients who received Class I restorations were not assessed as these restorations are limited to the chewing surface and not related to the health of gums.

  18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.

Study Arms (2)

Adhesive without acid pretreatment

EXPERIMENTAL

Experimental adhesive w/out phosphoric acid in post. rest.

Device: Experimental adhesive w/out phosphoric acid in post. rest.

Adhesive with acid pretreatment

ACTIVE COMPARATOR

Experimental adhesive with phosphoric acid in post. rest.

Device: Experimental adhesive with phosphoric acid in post. rest.

Interventions

Experimental adhesive w/out phosphoric acid in post. rest. DEVICE

Experimental adhesive without phosphoric acid in posterior restorations

Adhesive without acid pretreatment

Experimental adhesive with phosphoric acid in post. rest. DEVICE

Experimental adhesive with phosphoric acid in posterior restorations

Adhesive with acid pretreatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in need of Class I and Class II restorations in premolars and molars.

You may not qualify if:

• Patients with fewer than 20 teeth
• Patients exhibiting poor oral hygiene or uncontrolled periodontal disease
• Pregnant women or lactating mothers
• Patients with known allergies to HEMA or resin-based materials
• Patients with medical conditions that would contraindicate dental treatment
• Patients with xerostomia

Sponsors & Collaborators

• Dentsply International: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Ricardo Walter
• Organization: University of Pennslyvania

walterr@dental.upenn.edu

215-898-9164

Study Officials

• Ricardo Walter, DDS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Alan M. Atlas, DMD

  Academy House of Professional Offices

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 26, 2014
• Study Start: April 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 28, 2022
• Results First Posted: November 28, 2022

Record last verified: 2022-11