Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity

Dentinal Hypersensitivity Clinical Trial

Official title:

Lower-level Laser for Treating Dentinal Hypersensitivity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03553290
• Other study ID #: 201701057DIPA
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: March 2018
• Source: National Taiwan University Hospital
• Contact: Po-Chun Chang
• Phone: 02-23123456
• Email: changpc[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the efficacy of low energy laser for the treatment of dentinal hypersensitivity due to periodontal therapy.

Description:

We will recruit 80 adult patients with obvious symptom of hypersensitivity after periodontal therapy. They will receive low-energy laser treatment, and the area without the symptom of hypersensitivity will be served as control. Changes in pain status and clinical periodontal index within six months of treatment will be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion criteria

1.20-80 year-old with their own will and oral cleaning ability 2.Patients who have been diagnosed with periodontitis and have completed periodontal treatment 3.Gingival recession in at least two regions showed sensitivity of teeth (VAS> 5) 4.No systemic infection 5.No painkillers in the past two weeks 6.Not pregnant or lactating

Exclusion criteria

1.Smoking more than half a pack a day in the past month

Related Conditions & MeSH terms

• Dentinal Hypersensitivity
• Hypersensitivity

Intervention

Device:
• A.R.C. FOX Laser-FOX Q-810nm
805-810 nm dichotomous laser, 12 Watt within the power of sensitive parts of the affected teeth

Procedure:
• Control
Mechanical debridement alone

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mental status	Visual analogue scale analysis with a score range of 0-10 (0: no discomfort; 10: severe discomfort). Lower score represent a better outcome.	6 months
Secondary	Change in probing depth	Measure at six surfaces of tooth	6 months
Secondary	Change in clinical attachment level	Measure at six surfaces of tooth	6 months
Secondary	Change in gingival recession	Measure at six surfaces of tooth	6 months
Secondary	Change in masticatory mucosa	Measure at mid-buccal aspect of tooth	6 months