PMID- 33175253
OWN - NLM
STAT- MEDLINE
DCOM- 20210423
LR  - 20210511
IS  - 1436-3771 (Electronic)
IS  - 1432-6981 (Print)
IS  - 1432-6981 (Linking)
VI  - 25
IP  - 5
DP  - 2021 May
TI  - Saliva substitute mouthwash in nasopharyngeal cancer survivors with xerostomia: a 
      randomized controlled trial.
PG  - 3105-3115
LID - 10.1007/s00784-020-03634-5 [doi]
AB  - OBJECTIVES: Xerostomia is a prevalent sequelae among nasopharyngeal cancer (NPC) 
      survivors; yet, effective treatment protocols have been elusive. This study was a 
      prospective randomized clinical trial to compare the effects of saliva substitute 
      mouthwash in nasopharyngeal cancer survivors with xerostomia, between two 
      treatment arms, conducted in a tertiary center. MATERIALS AND METHODS: This study 
      measured the effects within 4 weeks in relation to summated xerostomia inventory 
      (SXI) and unstimulated whole saliva (UWS). Patients randomized into the 
      interventional arm were prescribed an immunologically active saliva substitute 
      (IASS), while patients in the control arm were prescribed a non-immunologically 
      active mouthwash as placebo. RESULTS: The study population consisted of 94 
      patients. There was a significant difference in SXI difference (p < 0.0001) and 
      UWS difference (p < 0.0001) between control and interventional arms. No harmful 
      side effects associated with the use of either mouthwash encountered throughout 
      the study duration. CONCLUSION: IASS mouthwash significantly reduces subjective 
      xerostomia scores measured using SXI and improves objective measurement of 
      salivary flow using UWS among nasopharyngeal cancer survivors with xerostomia. 
      CLINICAL RELEVANCE: IASS is significantly more effective in improving subjective 
      and objective xerostomia measurements compared to non-immunologically active 
      mouthwash. Additionally, this treatment is very safe, with superior side effect 
      profiles. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04491435.
FAU - Marimuthu, Dayaabaran
AU  - Marimuthu D
AD  - Department of Otorhinolaryngology and Head and Neck Surgery, Level 9, Clinical 
      Block, UKM Medical Centre, National University of Malaysia Kuala Lumpur Campus, 
      Jalan Yaacob Latiff, Bandar Tun Razak, 56000, Kuala Lumpur, Malaysia.
FAU - Han, Kong Min
AU  - Han KM
AD  - Department of Otorhinolaryngology and Head and Neck Surgery, Level 9, Clinical 
      Block, UKM Medical Centre, National University of Malaysia Kuala Lumpur Campus, 
      Jalan Yaacob Latiff, Bandar Tun Razak, 56000, Kuala Lumpur, Malaysia.
FAU - Mohamad, Mohd Shawal Firdaus
AU  - Mohamad MSF
AD  - Centre of Studies for Oral and Maxillofacial Surgery, Faculty of Dentistry, UiTM 
      Sungai Buloh Campus, Jalan Hospital, 47000, Sugai Buloh, Selangor, Malaysia.
FAU - Azman, Mawaddah
AU  - Azman M
AUID- ORCID: 0000-0001-9138-2849
AD  - Department of Otorhinolaryngology and Head and Neck Surgery, Level 9, Clinical 
      Block, UKM Medical Centre, National University of Malaysia Kuala Lumpur Campus, 
      Jalan Yaacob Latiff, Bandar Tun Razak, 56000, Kuala Lumpur, Malaysia. 
      mawaddah1504@yahoo.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT04491435
GR  - FF-2018-133/Universiti Kebangsaan Malaysia/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20201111
PL  - Germany
TA  - Clin Oral Investig
JT  - Clinical oral investigations
JID - 9707115
RN  - 0 (Mouthwashes)
MH  - Humans
MH  - Mouthwashes/therapeutic use
MH  - *Nasopharyngeal Neoplasms/drug therapy
MH  - Prospective Studies
MH  - Saliva
MH  - Survivors
MH  - *Xerostomia/drug therapy/etiology
PMC - PMC8060215
OTO - NOTNLM
OT  - Hyposalivation
OT  - Mouth dryness
OT  - Mouthwashes
OT  - Nasopharyngeal cancer
OT  - Radiation-induced toxicity
OT  - Saliva artificial
OT  - Saliva substitute
OT  - Xerostomia
COIS- The authors declare that they have no conflict of interest.
EDAT- 2020/11/12 06:00
MHDA- 2021/04/24 06:00
PMCR- 2020/11/11
CRDT- 2020/11/11 12:14
PHST- 2020/08/13 00:00 [received]
PHST- 2020/10/07 00:00 [accepted]
PHST- 2020/11/12 06:00 [pubmed]
PHST- 2021/04/24 06:00 [medline]
PHST- 2020/11/11 12:14 [entrez]
PHST- 2020/11/11 00:00 [pmc-release]
AID - 10.1007/s00784-020-03634-5 [pii]
AID - 3634 [pii]
AID - 10.1007/s00784-020-03634-5 [doi]
PST - ppublish
SO  - Clin Oral Investig. 2021 May;25(5):3105-3115. doi: 10.1007/s00784-020-03634-5. 
      Epub 2020 Nov 11.