NCT02931357

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_3

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

September 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

Same day

First QC Date

September 29, 2016

Last Update Submit

September 30, 2019

Conditions

Pain Teeth

Keywords

Treatment of teething in infants

Outcome Measures

Primary Outcomes (1)

  • Teething pain

    scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2

    day 0, 3 and 7

Secondary Outcomes (5)

  • day pain

    day 0, 3 and 7

  • gingival rush

    day 0, 3 and 7

  • hyper-salivation

    day 0, 3 and 7

  • redness

    day 0, 3 and 7

  • swelling

    day 0, 3 and 7

Study Arms (2)

Hyaluronic Acid 0.54%

EXPERIMENTAL

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

Device: Hyaluronic Acid 0.54%

Calgel®

ACTIVE COMPARATOR

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.

Drug: Calgel®

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

Also known as: Hyaluronic Acid gel 0.54%.
Hyaluronic Acid 0.54%
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.

Also known as: Lidocaine 0.33% and Cetylpyridinium Chloride 0.10%
Calgel®

Eligibility Criteria

Age3 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female infants aged between 6 and 36 months.
  • Teething diagnosed by the presence of at least 3 of the following clinical symptoms:
  • pain, swelling, gingival rush, hyper-salivation, redness, abnormal teeth depth.
  • Informed consent form signed by parents or legal representative.
  • Infants and parents who are in a general position to follow all study requirements

You may not qualify if:

  • Infants in hospitalization and/or immobilization and/or confinement to bed.
  • Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems
  • Concomitant use during the period of study of NSAIDs and/or any anesthetics (obviously Calgel® is allowed in patients randomized in group B, only)
  • Subjects with known history of allergic or adverse reactions to avian proteins or to HA and to any ingredient of the Medical Device and/or of the comparator on study.
  • Infants whose parents suffer from any form of psychiatric disorder or other condition which, in the opinion of the Investigator, might invalidate the required prescription and/or observation or complicate communication with the subject.
  • Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial.
  • Infants already treated under this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Opera Contract Research Organization SRL

Timișoara, Timiș County, 300209, Romania

Location

Related Publications (19)

  • Pytlik W. [Symptoms of the failure of the biological mechanism of teething. Symptomatology of the primary teeth's reinclusion]. Czas Stomatol. 1989 Jan;42(1):29-34. Polish.

    PMID: 2640634BACKGROUND

  • McIntyre GT, McIntyre GM. Teething troubles? Br Dent J. 2002 Mar 9;192(5):251-5. doi: 10.1038/sj.bdj.4801349.

    PMID: 11924952BACKGROUND

  • Owais AI, Zawaideh F, Al-Batayneh OB. Challenging parents' myths regarding their children's teething. Int J Dent Hyg. 2010 Feb;8(1):28-34. doi: 10.1111/j.1601-5037.2009.00412.x.

    PMID: 20096079BACKGROUND

  • Curtis LA, Dolan TS, Seibert HE. Are one or two dangerous? Lidocaine and topical anesthetic exposures in children. J Emerg Med. 2009 Jul;37(1):32-9. doi: 10.1016/j.jemermed.2007.11.005. Epub 2008 Feb 14.

    PMID: 18280086BACKGROUND

  • Weigel PH, Fuller GM, LeBoeuf RD. A model for the role of hyaluronic acid and fibrin in the early events during the inflammatory response and wound healing. J Theor Biol. 1986 Mar 21;119(2):219-34. doi: 10.1016/s0022-5193(86)80076-5.

    PMID: 3736072BACKGROUND

  • Bartold PM. The effect of interleukin-1 beta on hyaluronic acid synthesized by adult human gingival fibroblasts in vitro. J Periodontal Res. 1988 Mar;23(2):139-47. doi: 10.1111/j.1600-0765.1988.tb01347.x. No abstract available.

    PMID: 2967366BACKGROUND

  • Oksala O, Salo T, Tammi R, Hakkinen L, Jalkanen M, Inki P, Larjava H. Expression of proteoglycans and hyaluronan during wound healing. J Histochem Cytochem. 1995 Feb;43(2):125-35. doi: 10.1177/43.2.7529785.

    PMID: 7529785BACKGROUND

  • Irwin CR, Schor SL, Ferguson MW. Effects of cytokines on gingival fibroblasts in vitro are modulated by the extracellular matrix. J Periodontal Res. 1994 Sep;29(5):309-17. doi: 10.1111/j.1600-0765.1994.tb01227.x.

    PMID: 7799210BACKGROUND

  • Pistorius A, Martin M, Willershausen B, Rockmann P. The clinical application of hyaluronic acid in gingivitis therapy. Quintessence Int. 2005 Jul-Aug;36(7-8):531-8.

    PMID: 15999421BACKGROUND

  • Brandt FS, Cazzaniga A. Hyaluronic acid gel fillers in the management of facial aging. Clin Interv Aging. 2008;3(1):153-9. doi: 10.2147/cia.s2135.

    PMID: 18488885BACKGROUND

  • Dagenais S. Intra-articular hyaluronic acid (viscosupplementation) for knee osteoarthritis. Issues Emerg Health Technol. 2006 Nov;(94):1-4.

    PMID: 17096501BACKGROUND

  • Fernandez Lopez JC, Ruano-Ravina A. Efficacy and safety of intraarticular hyaluronic acid in the treatment of hip osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2006 Dec;14(12):1306-11. doi: 10.1016/j.joca.2006.08.003. Epub 2006 Sep 18.

    PMID: 16979914BACKGROUND

  • Iavazzo C, Athanasiou S, Pitsouni E, Falagas ME. Hyaluronic acid: an effective alternative treatment of interstitial cystitis, recurrent urinary tract infections, and hemorrhagic cystitis? Eur Urol. 2007 Jun;51(6):1534-40; discussion 1540-1. doi: 10.1016/j.eururo.2007.03.020. Epub 2007 Mar 20.

    PMID: 17383810BACKGROUND

  • Liguori V, Guillemin C, Pesce GF, Mirimanoff RO, Bernier J. Double-blind, randomized clinical study comparing hyaluronic acid cream to placebo in patients treated with radiotherapy. Radiother Oncol. 1997 Feb;42(2):155-61. doi: 10.1016/s0167-8140(96)01882-8.

    PMID: 9106924BACKGROUND

  • Igic M, Mihailovic D, Kesic L, Apostolovic M, Kostadinovic L, Janjic OT, Milasin J. [Efficacy of hyaluronic acid in the treatment of chronic gingivitis in children]. Vojnosanit Pregl. 2011 Dec;68(12):1021-5. doi: 10.2298/vsp1112021i. Serbian.

    PMID: 22352262BACKGROUND

  • Mesa FL, Aneiros J, Cabrera A, Bravo M, Caballero T, Revelles F, del Moral RG, O'Valle F. Antiproliferative effect of topic hyaluronic acid gel. Study in gingival biopsies of patients with periodontal disease. Histol Histopathol. 2002;17(3):747-53. doi: 10.14670/HH-17.747.

    PMID: 12168783BACKGROUND

  • Moseley R, Waddington RJ, Embery G. Hyaluronan and its potential role in periodontal healing. Dent Update. 2002 Apr;29(3):144-8. doi: 10.12968/denu.2002.29.3.144.

    PMID: 11989392BACKGROUND

  • Nolan A, Baillie C, Badminton J, Rudralingham M, Seymour RA. The efficacy of topical hyaluronic acid in the management of recurrent aphthous ulceration. J Oral Pathol Med. 2006 Sep;35(8):461-5. doi: 10.1111/j.1600-0714.2006.00433.x.

    PMID: 16918596BACKGROUND

  • Nolan A, Badminton J, Maguire J, Seymour RA. The efficacy of topical hyaluronic acid in the management of oral lichen planus. J Oral Pathol Med. 2009 Mar;38(3):299-303. doi: 10.1111/j.1600-0714.2008.00739.x.

    PMID: 19267842BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Serban Rosu, MD

    Societatea Civile Medicala Dr.Rosu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 13, 2016

Study Start

September 1, 2013

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

October 2, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)