NCT02306486

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
Last Updated

December 3, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

November 24, 2014

Last Update Submit

December 2, 2014

Conditions

Pain

Outcome Measures

Primary Outcomes (5)

  • teeth sensitivity by EVA

    days after of placing the restorations

    30 days

  • teeth sensitivity by EVA

    days after of placing the restorations

    60 days

  • teeth sensitivity by EVA

    days after of placing the restorations

    90 days

  • teeth sensitivity by EVA

    days after of placing the restorations

    180 days

  • teeth sensitivity by EVA

    days after of placing the restorations

    360 days

Study Arms (4)

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)

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

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:)

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

Interventions

with 0,5% oxalic acid (Desenssiv SSWhite)OTHER

with 0,5% oxalic acid (Desenssiv SSWhite) , desensitizer for sensivity cervical lesions on tooth

Also known as: Desenssiv SSWhite
p 90 resin composite + oxalic acidz250 resin composite + oxalic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Barrientos C, Xaus G, Leighton C, Martin J, Gordan VV, Moncada G. Oxalic acid under adhesive restorations as a means to reduce dentin sensitivity: a four-month clinical trial. Oper Dent. 2011 Mar-Apr;36(2):126-32. doi: 10.2341/09-364-C.

    PMID: 21777095BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eduardo Fernandez, Prof.

    University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Eduardo Fernández G.

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 3, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 3, 2014

Record last verified: 2014-11