CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 54 enrolled
Drug / intervention
Calgel® +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02931357
NCT02931357Phase 3Completed
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A Randomized, Open, Parallel-group Multicenter Study of Efficacy and Tolerability of a New Medical Device in Gel Formulation (Hyaluronic Acid 0.54%) Versus Calgel® for the Topical Treatment of Teething in Infants

Ricerfarma S.r.l·interventional·Posted Oct 13, 2016·Updated Oct 2, 2019

In Brief

A Phase 3 clinical trial evaluating Hyaluronic Acid 0.54% and Calgel® for Pain Teeth. Completed, enrolled 54 participants across 1 site.

Detailed Summary

This is a randomized, open label, parallel-groups, multicenter study. The study will be conducted in three clinical sites. Test Medical Device: 0.54% Hyaluronic Acid rose honey flavour gel medical device class IIa.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain Teeth
CountriesRomania
CollaboratorsOpera CRO, a TIGERMED Group Company, Latis S.r.l.

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 13, 2016
Enrollment StartSep 1, 2013
Primary CompletionSep 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 9.7 years ago

Interventions

Hyaluronic Acid 0.54%device

Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day

Calgel®drug

Administration: application of the gel on the gingival tissue, massage it in gently, three/four times a day (away from meals). In any case the interval between gel applications must be at least 3 hours.