PMID- 33214593
OWN - NLM
STAT- MEDLINE
DCOM- 20210113
LR  - 20210113
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 10
IP  - 1
DP  - 2020 Nov 19
TI  - Efficacy of P(11)-4 for the treatment of initial buccal caries: a randomized 
      clinical trial.
PG  - 20211
LID - 10.1038/s41598-020-77057-3 [doi]
LID - 20211
AB  - To investigate the safety and efficacy of Self-Assembling Peptide P(11)-4 (SAP 
      P(11)-4) compared to placebo or fluoride varnish (FV), a randomized, controlled, 
      blinded, split-mouth study with sequential design was conducted. Subjects 
      presenting two teeth with White-Spot-Lesions (WSLs) were included and teeth were 
      randomly assigned to test or control. Control received placebo at baseline (D0) 
      and test SAP P(11)-4, all received FV at Day 90 (D90). Standardized photographs 
      were taken at each visit, and WSL size changes were morphometrically assessed. 
      Hierarchical Linear Modelling, considering paired and sequential design, was used 
      to test four hypotheses. SAP P(11)-4 lesions (test, D90-D0) showed significant 
      WSL size reduction compared to placebo (control, D90-D0; p = 0.008) or FV 
      (control, D180-D90; p = 0.001). Combination of SAP P(11)-4 and delayed FV after 
      90 days (test, D180-D0), showed a significant difference compared to FV alone 
      (control D270-D90; p = 0.003). No significant difference on FV efficacy was found 
      when SAP P(11)-4 was applied 3 months before FV (test D270-D90; control D270-D90, 
      p = 0.70). SAP P(11)-4 treatment resulted in superior caries regression compared 
      to either placebo or FV, and FV efficacy seems not to be affected by SAP P(11)-4. 
      SAP P(11)-4 was found to be a safe and effective WSL treatment.
FAU - Sedlakova Kondelova, Paulina
AU  - Sedlakova Kondelova P
AD  - University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, 
      Geneva 4, Switzerland.
FAU - Mannaa, Alaa
AU  - Mannaa A
AD  - Division of Operative Dentistry, Department of Restorative Dentistry, Faculty of 
      Dentistry, King Abdulaziz University, P.O. Box 80209, Jeddah, 21589, Kingdom of 
      Saudi Arabia.
FAU - Bommer, Claudine
AU  - Bommer C
AD  - Credentis AG, Dorfstrasse 69, 5210, Windisch, Switzerland.
FAU - Abdelaziz, Marwa
AU  - Abdelaziz M
AD  - University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, 
      Geneva 4, Switzerland.
FAU - Daeniker, Laurent
AU  - Daeniker L
AD  - University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, 
      Geneva 4, Switzerland.
FAU - di Bella, Enrico
AU  - di Bella E
AD  - Department of Political Sciences, University of Genova, P.le E. Brignole 3a, 
      16126, Genova, Italy.
FAU - Krejci, Ivo
AU  - Krejci I
AD  - University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, 
      Geneva 4, Switzerland. Ivo.Krejci@unige.ch.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201119
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Cariostatic Agents)
RN  - 0 (Fluorides, Topical)
RN  - 0 (Oligopeptides)
RN  - 0 (P11-4 peptide)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Cariostatic Agents/*therapeutic use
MH  - Dental Caries/*drug therapy
MH  - Female
MH  - Fluorides, Topical/*therapeutic use
MH  - Humans
MH  - Male
MH  - Oligopeptides/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC7678830
COIS- C. Bommer is an employee of credentis. All other authors declare no competing 
      interests.
EDAT- 2020/11/21 06:00
MHDA- 2021/01/14 06:00
PMCR- 2020/11/19
CRDT- 2020/11/20 05:46
PHST- 2020/05/05 00:00 [received]
PHST- 2020/10/09 00:00 [accepted]
PHST- 2020/11/20 05:46 [entrez]
PHST- 2020/11/21 06:00 [pubmed]
PHST- 2021/01/14 06:00 [medline]
PHST- 2020/11/19 00:00 [pmc-release]
AID - 10.1038/s41598-020-77057-3 [pii]
AID - 77057 [pii]
AID - 10.1038/s41598-020-77057-3 [doi]
PST - epublish
SO  - Sci Rep. 2020 Nov 19;10(1):20211. doi: 10.1038/s41598-020-77057-3.