Clinical trial NCT04351412: Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period
Official title: Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period Between a Single Topical Application of a Dentin-desensitizing Agent (Gluma) and Other Materials: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Gluma
Desensitizing agent
Hypersensitivity
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, clinical trial
Primary purpose: TREATMENT

Brief summary: Here we assessed the clinical effectiveness of Gluma, fluoride varnish, and the Tetric N-Bond one-step self-etch system in alleviating DH instantly and over 1 month, after a single topical application.A randomized, double-blind, clinical trial was conducted on 55 patients (25 males, 30 females; age: 20-49 years). Seventy teeth were randomly assigned to three groups: Gluma (n = 24); fluoride varnish (n = 23); and Tetric N-Bond adhesive (n = 23). Sensitivity to tactile, air blast, and cold stimuli were investigated.. A visual analogue scale was used to assess tactile stimuli, and the Schiff Cold Scale to assess air blast and cold stimuli. DH was evaluated immediately post-treatment, and at the 2-week and 1-month follow-up. Between-group and within-group comparisons were made.


Eligibility criteria: Inclusion Criteria:

* Middle-aged adult population who usually complains of Dentin Hypersensitivity.
* Age range 20-49 years, that visit the dental hospital at King Abdul-Aziz university (KAUDH) who would have at least one or two teeth with DH
* Those with recession of the gingiva, teeth erosion or abrasion.
* Patients agreed to participate in the study.

Exclusion Criteria:

* Patients going through professional desensitizing treatment during the previous three months; Using desensitizing tooth paste in the last two months
* Chronic; far on progress periodontal disease; treatment for periodontal disease;
* Teeth with ICDAS (International Caries Detection and Assessment System) score 4
* Teeth diagnosed for irreversible pulpitis; root canal treated teeth
* Teeth covered with crowns; bridge
* Teeth with cervical restorations interfering with the evaluation
* Medically compromised patients currently using medications like anticonvulsants, antihistamines, antidepressants, sedatives or daily analgesics.
* Pregnant or lactating women; were also excluded.

Primary outcomes:
measure: Assess dentine hypersensitivity score to stimuli at Baseline
timeFrame: Baseline before treatment
measure: Assess dentine hypersensitivity score to stimuli immediately after treatment by intervention
timeFrame: From baseline to immediately after treatment with intervention
measure: Assess dentine hypersensitivity to stimuli at two-weeks follow up after treatment by intervention
timeFrame: From baseline to two-weeks follow up after treatment with intervention
measure: Assess dentine hypersensitivity to stimuli at one month follow up after treatment by intervention
timeFrame: From baseline to one month follow up after treatment with intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
Study officials:
affiliation: Assistant Professor, Department of Restorative Dentistry, King Abdul-Aziz University, Jeddah, Saudi Arabia
name: Samar H Abuzinadah, DScD
role: STUDY_CHAIR
affiliation: Assistant Professor, Department of Oral and Maxillofacial Prosthodontics, King Abdul-Aziz University, Jeddah, Saudi Arabia
name: Abdulrahman J Alhaddad, DScD
role: STUDY_DIRECTOR
References:
citation: Abuzinadah SH, Alhaddad AJ. A randomized clinical trial of dentin hypersensitivity reduction over one month after a single topical application of comparable materials. Sci Rep. 2021 Mar 24;11(1):6793. doi: 10.1038/s41598-021-86258-3.