The Effect of Oxalic Acid on Cervical Restorations on Hypersensitive Teeth, a Double-blind Randomized Controlled Clinical Trial. One Year Follow up

University of Chile0 sites31 target enrollmentStarted: January 1, 2012Last updated: December 3, 2014

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 31
Primary Endpoint: teeth sensitivity by EVA

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

The aim of this double-blind randomized controlled clinical trial was to evaluate the effect on dentin sensitivity using oxalic acid desensitizing agent before restoring with resin-based-composites, during one-year follow-up. One hundred and twenty two cervical lesions (31 patients, age range between 24 and 66 years) were selected and randomly divided into four groups: OA/Z250: treated with acid oxalic desensitizing agent (Desenssiv, SSWhite) before restoring with a methacrylate resin-based-composite (Z250, 3M ESPE), (n=31), OA/P90 treated with acid oxalic desensitizing agent (Desenssiv, SSWhite) before restoring with a silorane resin-based-composite (Silorane p90, 3M ESPE) (n=31), Z250 restored with methacrylate resin-based-composite (Z250, 3M ESPE) (n=30) and P90 restored with a silorane resin-based-composite (Silorane p90, 3M ESPE) (n=30). All lesions were evaluated at baseline, immediately and 1, 2, 3, 6 months and 1 year after treatment. Teeth sensitivity was measured by visual analog scale (VAS) after evaporation and tactile stimuli

Detailed Description

The study design was a split-mouth placebo-controlled randomized clinical trial according to CONSORT recommendations. Patients were recruited in the Clinic of Dental School of University of Chile according to inclusion criteria.All patients signed the informed consent approved by the Ethics Committee (Dental School, Universidad de Chile).

Inclusion criteria were:

Patients older than 18 years old having at least 4 teeth with cervical buccal lesions sensitive to tactile and thermal/evaporation stimuli. (moderate / severe pain by EVA)
Teeth with surface loss on the buccal cervical area with indication of resin-composite-based restoration.

Exclusion criteria were:

Systemic diseases related to chronic pain
Pregnancy
Recent periodontal surgery, orthodontic treatment or desensitizing treatment within the last 3 months.
In treatment with NSAIDs
Teeth with caries or restorations
Incisor teeth (to avoid cross innervation).

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Patients older than 18 years old having at least 4 teeth with cervical buccal lesions sensitive to tactile and thermal/evaporation stimuli. (moderate / severe pain by EVA)
•Teeth with surface loss on the buccal cervical area with indication of resin-composite-based restoration.

Exclusion Criteria

•-Systemic diseases related to chronic pain
•Pregnancy
•Recent periodontal surgery, orthodontic treatment or desensitizing treatment within the last 3 months.
•In treatment with NSAIDs
•Teeth with caries or restorations
•Incisor teeth (to avoid cross innervation).

Arms & Interventions

z250 resin composite

Placebo Comparator

(n=31) Treated with distilled water (placebo) and restored with a methacrylate resin-based-composite (Z250, 3M ESPE, shade: A3)

z250 resin composite + oxalic acid

Active Comparator

(n=31) treated with 0.5% oxalic acid (Desenssiv, SSWhite)(intervention)// and restored with a methacrylate resin-based-composite (Z250, 3M ESPE, shade: A3)

Intervention: with 0,5% oxalic acid (Desenssiv SSWhite) (Other)

p 90 resin composite

Placebo Comparator

(n=31) Treated with distilled water (placebo) and restored with a silorane resin-based-composite.

p 90 resin composite + oxalic acid

Active Comparator

(n=31) treated with 0,5% oxalic acid (Desenssiv SSWhite)(Intervention)/ and restored with a silorane resin-based-composite (Filtek Silorane p90, £M ESPE, shade:)

Intervention: with 0,5% oxalic acid (Desenssiv SSWhite) (Other)