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Pain TeethPhase 3NCT02931357

Study of a New Medical Device in Gel Formulation Versus Calgel® for the Topical Treatment of Teething in Infants

A Phase 3 study testing Hyaluronic Acid 0.54% and Calgel® in people with Pain Teeth, run by Ricerfarma S.r.l at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 36 months
Conditions the study is for
Pain Teeth
What is being tested?
Hyaluronic Acid 0.54% and Calgel®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteRomania
Study dates
Sep 2013to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 36 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
  • At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
  • Informed consent form signed by parents or legal representative.
  • Infants and parents who are in a general position to follow all study requirements

Who cannot join

  • 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
  • Use of topical Lidocaine and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.
  • Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.
  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Romania1 site

  • Opera Contract Research Organization SRL

    Timișoara, Timiș County, 300209

Other trials in Romania

About this study

Official title: 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

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.

Read the detailed description

Due to the potentially serious toxicity that can result from the use of topical anesthetics to relieving the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products containing Hyaluronic Acid have been marketed in Europe. In particular, Ricerfarma is developing several high molecular weight Hyaluronic Acid medical devices characterized by the absence of preservatives, alcohol and dyes; therefore, the administration of these products in infants is safe and can help creating a natural protective layer on the gingival tissue. In previous clinical trials with these high molecular weight Hyaluronic Acid medical devices it was noted a periodontal tissue/fluid balance with accelerated healing and repair properties that could be of interest either for accelerating the wound healing process or for treating the complex physical symptoms (i.e. soreness and swelling of gums, crying, sleeplessness) related to the teething in infants. These data were confirmed by a recent pilot study on 18 infants suffering by teething where the two formulation of the tested high molecular weight Hyaluronic Acid medical device evidenced, at the end of treatment period, for pain, swelling, gingival rush, hyper-salivation and redness a statistically significant reduction from baseline.

Conditions
Pain Teeth
Being tested
Hyaluronic Acid 0.54%, Calgel®
Keywords
Treatment of teething in infants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyaluronic Acid 0.54%Device

    Also called Hyaluronic Acid gel 0.54%.

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

  • Calgel®Drug

    Also called Lidocaine 0.33% and Cetylpyridinium Chloride 0.10%

    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.

Study groups in NCT02931357
Study groupRoleWhat they receive
Hyaluronic Acid 0.54%ExperimentalAdministration: application of the gel on the gingival tissue, massage it in gently, five to six times a day.
Receives: Device: Hyaluronic Acid 0.54%
Calgel®Active comparatorAdministration: 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.
Receives: Drug: Calgel®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Teething pain

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

    Measured: day 0, 3 and 7

Secondary outcomes (5)

  1. day pain

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

    Measured: day 0, 3 and 7

  2. gingival rush

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

    Measured: day 0, 3 and 7

  3. hyper-salivation

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

    Measured: day 0, 3 and 7

  4. redness

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

    Measured: day 0, 3 and 7

  5. swelling

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

    Measured: day 0, 3 and 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02931357
Sponsor's protocol ID
GENG10-12
Status last verified
Sep 2019
First submitted
29 Sep 2016
Last updated
2 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 2640634

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

    PubMed 11924952

  • 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.

    PubMed 20096079

  • 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.

    PubMed 18280086

  • 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.

    PubMed 3736072

  • 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.

    PubMed 2967366

  • 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.

    PubMed 7529785

  • 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.

    PubMed 7799210

  • 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.

    PubMed 15999421

  • 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.

    PubMed 18488885

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

    PubMed 17096501

  • 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.

    PubMed 16979914

  • 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.

    PubMed 17383810

  • 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.

    PubMed 9106924

  • 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.

    PubMed 22352262

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hyaluronic Acid 0.54% and Calgel® in people with Pain Teeth, run by Ricerfarma S.r.l at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Teething pain (time frame: day 0, 3 and 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02931357, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.

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