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.
Comparison of Clinical Effectiveness of Hydrochloric Acid and Sodium Hypochlorite Used in Microabrasion Technique for the Treatment of Dental Fluorosis.
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedFirst Submitted
Initial submission to the registry
March 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedMay 2, 2022
April 1, 2022
6 months
March 20, 2022
April 26, 2022
Conditions
Keywords
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)
EXPERIMENTALTotal 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.
GROUP B ( SODIUM HYPOCHLORITE)
EXPERIMENTALTotal 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. .
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.
Eligibility Criteria
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
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.
PMID: 32149058RESULTSheoran 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.
PMID: 24588784RESULTGupta 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.
PMID: 28762354RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
HAREEM A SATTAR, FCPS
Fatima Jinnah Dental College
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