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CompletedNCT05339503Updated May 2, 2022

This is the Comparison of Clinical Effectiveness of Hydrochloric Acid-pumice Compound and Sodium Hypochlorite-pumice Compound Used in Microabrasion Technique for the Treatment of Dental Fluorosis. Change in Tooth Shade Was Checked Before and After the Procedure.

An interventional study of enamel microabrasion in Dental Fluoroses, sponsored by Fatima Jinnah Dental College. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-02.

Sponsored by Fatima Jinnah Dental College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Nov 2019, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Dental Fluoroses

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Keywords

  • Hydrochloric Acid
  • Sodium Hypochlorite
  • Dental Fluorosis
  • Microabrasion Technique
03

In context

Fluorosis, Dental

24 studies on the registry are indexed under Fluorosis, Dental; 4 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 18 interventional studies indexed under Fluorosis, Dental.

Browse Fluorosis, Dental studies →

Lead sponsor

Fatima Jinnah Dental College is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    GROUP A (HYDROCHLORIC ACID)

    Total 30 teeth in each group were included. Preoperatively shade was checked with VITA classical A1-D4® shade guide. The mixture (hydrochloric acid pumice compound) 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 change in shade was checked again with VITA classical A1-D4® shade guide.

    Other: enamel microabrasion

  • Experimental
    GROUP B ( SODIUM HYPOCHLORITE)

    Total 30 teeth in each group were included. Preoperatively shade was checked with VITA classical A1-D4® shade guide.The mixture (sodium hypochlorite pumice compound) 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 change in shade was checked again with VITA classical A1-D4® shade guide. .

    Other: enamel microabrasion

Interventions

  • Otherenamel 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 minutes

  2. 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.

    Time frame: 30 minutes

07

Study locations

1 site
  • Fatima Jinnah Dental College
    Karachi, Sindh 75400, Pakistan
08

References and documents

Publications

  • Nevarez-Rascon M, Molina-Frechero N, Adame E, Almeida E, Soto-Barreras U, Gaona E, Nevarez-Rascon 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;8(4):743-756. doi: 10.12998/wjcc.v8.i4.743. PubMed 32149058 ↗
  • 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. doi: 10.1111/jerd.12096. Epub 2014 Mar 4. PubMed 24588784 ↗
  • 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. PubMed 28762354 ↗

Individual participant data

Plan to share: No — i will share the IPD once it will get published

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05339503
Lead sponsor
Fatima Jinnah Dental College
Responsible party
HAREEM ABDUL SATTAR (Senior Registrar, Department of Operative Dentistry, Principal Investigator, Fatima Jinnah Dental College) — Principal investigator
First posted
Apr 21, 2022
Start date
Nov 1, 2019
Primary completion
Apr 30, 2020
Completion
Apr 30, 2020
Last update
May 2, 2022

Study contacts

HAREEM A SATTAR, FCPS
principal investigator · Fatima Jinnah Dental College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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