NCT05339503

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

March 20, 2022

Last Update Submit

April 26, 2022

Conditions

Keywords

Hydrochloric AcidSodium HypochloriteDental FluorosisMicroabrasion Technique

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

GROUP A (HYDROCHLORIC ACID)

EXPERIMENTAL

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

GROUP B ( SODIUM HYPOCHLORITE)

EXPERIMENTAL

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

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.

GROUP A (HYDROCHLORIC ACID)GROUP B ( SODIUM HYPOCHLORITE)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima Jinnah Dental College

Karachi, Sindh, 75400, Pakistan

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Fluorosis, Dental

Interventions

Enamel Microabrasion

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Esthetics, DentalDentistry

Study Officials

  • HAREEM A SATTAR, FCPS

    Fatima Jinnah Dental College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar, Department of Operative Dentistry, Principal Investigator

Study Record Dates

First Submitted

March 20, 2022

First Posted

April 21, 2022

Study Start

November 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

i will share the IPD once it will get published

Locations