N/A N=101 Randomized Double-blind Treatment

Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars

Pulpitis

Bottom Line

View on ClinicalTrials.gov: NCT04115358 ↗

Enrolled (actual)

101

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Number of Teeth Sensitive to Percussion in 3 Groups — 7; 6; 3 teeth — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hyaluronic acid: Gengigel teething (Procedure); Formocresol Buckley formula: Formacresol (Procedure); Ferric sulfate: ViscoStat (Procedure)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Marmara University
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Teeth Sensitive to Percussion in 3 Groups	2; 6; 2	>0.05
PRIMARY Number of Teeth Sensitive to Percussion in 3 Groups	2; 6; 2	>0.05
PRIMARY Number of Teeth Sensitive to Percussion in 3 Groups	2; 6; 2	>0.05
PRIMARY Number of Teeth Sensitive to Percussion in 3 Groups	2; 6; 2	>0.05
PRIMARY Number of Mobile Teeth in 3 Groups	4; 4; 3	>0.05
PRIMARY Number of Mobile Teeth in 3 Groups	4; 4; 3	>0.05
PRIMARY Number of Mobile Teeth in 3 Groups	4; 4; 3	>0.05
PRIMARY Number of Mobile Teeth in 3 Groups	4; 4; 3	>0.05
PRIMARY Number of Teeth With Patient Discomfort and/or Pain in 3 Groups	0; 0; 0	>0.05
PRIMARY Number of Teeth With Patient Discomfort and/or Pain in 3 Groups	0; 0; 0	>0.05
PRIMARY Number of Teeth With Patient Discomfort and/or Pain in 3 Groups	0; 0; 0	>0.05
PRIMARY Number of Teeth With Patient Discomfort and/or Pain in 3 Groups	0; 0; 0	>0.05
PRIMARY Number of Teeth With Dental Abscess in 3 Groups	0; 0; 0	>0.05
PRIMARY Number of Teeth With Dental Abscess in 3 Groups	0; 0; 0	>0.05
PRIMARY Number of Teeth With Dental Abscess in 3 Groups	0; 0; 0	>0.05
PRIMARY Number of Teeth With Dental Abscess in 3 Groups	0; 0; 0	>0.05
PRIMARY Number of the Pathological Exfoliation of Affected Teeth in 3 Groups	2; 0; 0	>0.05
PRIMARY Number of the Pathological Exfoliation of Affected Teeth in 3 Groups	2; 0; 0	>0.05
PRIMARY Number of the Pathological Exfoliation of Affected Teeth in 3 Groups	2; 0; 0	>0.05
PRIMARY Number of the Pathological Exfoliation of Affected Teeth in 3 Groups	2; 0; 0	>0.05
PRIMARY Number of Teeth With Root Resorption in 3 Groups	12; 8; 15; 11; 8; 5	>0.05
PRIMARY Number of Teeth With Root Resorption in 3 Groups	12; 8; 15; 11; 8; 5	>0.05
PRIMARY Number of Teeth With Root Resorption in 3 Groups	12; 8; 15; 11; 8; 5	>0.05
PRIMARY Number of Teeth With Root Resorption in 3 Groups	12; 8; 15; 11; 8; 5	>0.05
PRIMARY Number of Teeth With Any Root Lesion From Radiography in 3 Groups	4; 4; 2	>0.05
PRIMARY Number of Teeth With Any Root Lesion From Radiography in 3 Groups	4; 4; 2	>0.05
PRIMARY Number of Teeth With Any Root Lesion From Radiography in 3 Groups	4; 4; 2	>0.05
PRIMARY Number of Teeth With Any Root Lesion From Radiography in 3 Groups	4; 4; 2	>0.05
SECONDARY Restoration Stability	31; 28; 27; 17; 12; 11	>0.05
SECONDARY Restoration Stability	31; 28; 27; 17; 12; 11	>0.05
SECONDARY Restoration Stability	31; 28; 27; 17; 12; 11	>0.05
SECONDARY Restoration Stability	31; 28; 27; 17; 12; 11	>0.05

Summary

In this study, 120 primary molar teeth from healthy children aged between 5 and 9 and who apply to Marmara University Faculty of Dentistry, Department of Pediatric Dentistry will be subjected to pulpotomy treatments. After proper diagnosis of coronal pulpitis, the teeth will be assigned randomly to one of the 3 groups: 40 primary molars for formocresol (FC) pulpotomy treatments, 40 primary molars for ferric sulfate (FS) treatments and 40 primary molars for 0.5% hyaluronic acid gel (HA) pulpotomy treatments. The tooth decay will be removed, the pulp will be amputated from the chamber of the pulp with a sharp excavator and one of the medicament will be applied to the orifice of the root canals. The cavity will be sealed tight with zinc oxide cement, and the primary molars will be restored with a composite filling material or with a stainless steel crown (SSC). A single investigator will perform the procedure. The teeth will be followed clinically and radiographically at 1st, 3rd, 6th, 12th months.

Eligibility Criteria

Inclusion Criteria

No systemic disease,
No pathological mobility and/or resorption of the tooth,
No pain and/or abscess,
Parents volunteering,
The patients are between 5-9 years old.

Exclusion Criteria

Systemic disease,
Pathological mobility and resorption of the tooth,
Pain and/or abscess,
Non voluntary,
The patients aren't between 5-9 years old.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04115358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.