PMID- 32144336
OWN - NLM
STAT- MEDLINE
DCOM- 20201116
LR  - 20221005
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 10
IP  - 1
DP  - 2020 Mar 6
TI  - Randomized Clinical Trial investigating Self-Assembling Peptide P(11)-4 for 
      Treatment of Early Occlusal Caries.
PG  - 4195
LID - 10.1038/s41598-020-60815-8 [doi]
LID - 4195
AB  - Non-invasive caries treatment is a major focus in modern dentistry. The present 
      study was designed to evaluate the effectiveness of monomeric self-assembling 
      peptide P(11)-4 (SAP P(11)-4) in combination with fluoride varnish or polymeric 
      self-assembling peptide matrix (SAPM) in treatment of non-cavitated occlusal 
      caries. Ninety children and adolescents were included in this randomized, 
      gold-standard-controlled clinical trial. Test Group 1 received SAP P(11)-4 and 
      twice fluoride varnish at baseline and Day 180, Test Group 2 received SAP P(11)-4 
      on baseline and twice weekly SAPM (home-application), and Control Group received 
      fluoride varnish on baseline and Day 180. Caries progression was measured by 
      laser fluorescence, Nyvad Caries Activity, ICDAS-II-codes, and investigator 
      assessments. Laser fluorescence changes demonstrated superior results for Test 
      Group 1 and 2, as values decreased compared to an increase for the Control Group 
      (p < 0.0005). ICDAS-II codes at Day 360 showed partial regression for Test Group 
      1 (6.7%) and Test Group 2 (20.0%) and partial progression for Control Group 
      (23.3%) (p < 0.01). Nyvad Caries Activity yielded superior caries inactivation 
      for Test Groups, compared to Control Group (p = 0.002). This trial showed that 
      SAP P(11)-4, applied either in combination with fluoride varnish or twice weekly 
      SAPM, was a superior treatment for early caries compared to fluoride varnish 
      alone.
FAU - Doberdoli, Dafina
AU  - Doberdoli D
AUID- ORCID: 0000-0003-0362-1104
AD  - Department of Pediatric Dentistry and Prevention, University Dentistry Clinical 
      Center of Kosovo, Rrethi I spitalit p.n, Pristina, 10000, Kosovo. 
      dafina913@gmail.com.
AD  - School of Dental Medicine - Department of Pediatric Dentistry and Prevntion, 
      University of Zagreb, Gunduliceva 5, Zagreb, 10000, Croatia. dafina913@gmail.com.
FAU - Bommer, Claudine
AU  - Bommer C
AD  - credentis ag, Dorfstrasse 69, 5210, Windisch, Switzerland.
FAU - Begzati, Agim
AU  - Begzati A
AD  - Department of Pediatric Dentistry and Prevention, University Dentistry Clinical 
      Center of Kosovo, Rrethi I spitalit p.n, Pristina, 10000, Kosovo.
FAU - Haliti, Fehim
AU  - Haliti F
AD  - Department of Pediatric Dentistry and Prevention, University Dentistry Clinical 
      Center of Kosovo, Rrethi I spitalit p.n, Pristina, 10000, Kosovo.
FAU - Heinzel-Gutenbrunner, Monika
AU  - Heinzel-Gutenbrunner M
AD  - MH Statistics, 35041, Marburg, Germany.
FAU - Juric, Hrvoje
AU  - Juric H
AD  - School of Dental Medicine - Department of Pediatric Dentistry and Prevntion, 
      University of Zagreb, Gunduliceva 5, Zagreb, 10000, Croatia.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200306
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - EC 2.4.- (Glycosyltransferases)
RN  - EC 2.4.1.- (peptide P)
RN  - Q80VPU408O (Fluorides)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Dental Caries/*drug therapy
MH  - Female
MH  - Fluorides/therapeutic use
MH  - Glycosyltransferases/*therapeutic use
MH  - Humans
MH  - Male
MH  - Surveys and Questionnaires
PMC - PMC7060217
COIS- The authors declare competing interests. C. Bommer is an employee of credentis. 
      M. Heinzel-Gutenbrunner received compensation for the work performed within the 
      clinical study.
EDAT- 2020/03/08 06:00
MHDA- 2020/11/18 06:00
PMCR- 2020/03/06
CRDT- 2020/03/08 06:00
PHST- 2019/09/18 00:00 [received]
PHST- 2020/02/14 00:00 [accepted]
PHST- 2020/03/08 06:00 [entrez]
PHST- 2020/03/08 06:00 [pubmed]
PHST- 2020/11/18 06:00 [medline]
PHST- 2020/03/06 00:00 [pmc-release]
AID - 10.1038/s41598-020-60815-8 [pii]
AID - 60815 [pii]
AID - 10.1038/s41598-020-60815-8 [doi]
PST - epublish
SO  - Sci Rep. 2020 Mar 6;10(1):4195. doi: 10.1038/s41598-020-60815-8.