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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05339503
Other study ID # FatimaJDC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date April 30, 2020

Study information

Verified date April 2022
Source Fatima Jinnah Dental College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the clinical effectiveness of hydrochloric acid-pumice compound and sodium hypochlorite-pumice compound in treating dental fluorosis using microabrasion technique.


Description:

A Randomized Clinical Trial was taken Fatima Jinnah Dental College Hospital, Karachi, from 1st November 2019 To 30th April 2020. Total 30 teeth in each group were included. Preoperatively shade was checked. The mixture was applied 10 times or more during the same session. Total treatment time was around 30 minutes. Every patient received entire microabrasion treatment. At the end of the treatment, neutral sodium fluoride gel was applied. Then changes in shade were checked. Descriptive statistics were calculated.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Patients aged 18-40 years . - Permanent dentition assessed on clinical examination. - Have at least four maxillary incisors with scores of 4 to 5, according to the Dean's Fluorosis Index. - Have no caries or restoration on the teeth to be treated assessed clinically. Exclusion Criteria: - Poor oral dental and general health assessed on clinical examination. - History of Smoking and any form of tobacco. - Patients with periodontal disease assessed on clinical examination. - Caries on anterior teeth assessed on clinical examination. - Hypersensitive teeth assessed on clinical examination.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
enamel microabrasion
It is a non-restorative, conservative treatment that works both chemically and mechanically to remove up to 0.2 mm of affected enamel per application. Pumice either mixed with 18% hydrochloric acid or 5.25% sodium hypochlorite was used to remove fluorosis stains.

Locations

Country Name City State
Pakistan Fatima Jinnah Dental College Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Fatima Jinnah Dental College

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Gupta A, Dhingra R, Chaudhuri P, Gupta A. A comparison of various minimally invasive techniques for the removal of dental fluorosis stains in children. J Indian Soc Pedod Prev Dent. 2017 Jul-Sep;35(3):260-268. doi: 10.4103/JISPPD.JISPPD_138_16. — View Citation

Nevárez-Rascón M, Molina-Frechero N, Adame E, Almeida E, Soto-Barreras U, Gaona E, Nevárez-Rascón A. Effectiveness of a microabrasion technique using 16% HCL with manual application on fluorotic teeth: A series of studies. World J Clin Cases. 2020 Feb 26; — View Citation

Sheoran N, Garg S, Damle SG, Dhindsa A, Opal S, Gupta S. Esthetic management of developmental enamel opacities in young permanent maxillary incisors with two microabrasion techniques--a split mouth study. J Esthet Restor Dent. 2014 Sep-Oct;26(5):345-52. d — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary HYDROCHLORIC ACID PUMICE COMPOUND Tooth shade was recorded at the baseline with the help of VITA classical A1-D4® shade guide. The arrangement of the shades in the VITA classical family of shades is as follows: A1 - A4 (reddish-brownish), B1 - B4 (reddish-yellowish), C1 - C4 (greyish shades), D2 - D4 (reddish-grey).Determination of shade was done under daylight. Closest shade was selected from the shade tab. Effectiveness was marked positive if there was atleast one change in shade from the baseline just after the procedure to shade group from A1-D4. Effectiveness was marked negative if there is no change in shade from the baseline. 30 minutes
Primary SODIUM HYPOCHLORITE PUMICE COMPOUND Tooth shade was recorded at the baseline with the help of VITA classical A1-D4® shade guide. The arrangement of the shades in the VITA classical family of shades is as follows: A1 - A4 (reddish-brownish), B1 - B4 (reddish-yellowish), C1 - C4 (greyish shades), D2 - D4 (reddish-grey).Determination of shade was done under daylight. Closest shade was selected from the shade tab. Effectiveness was marked positive if there was atleast one change in shade from the baseline just after the procedure to shade group from A1-D4. Effectiveness was marked negative if there is no change in shade from the baseline. 30 minutes
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