Trial

Intervention

Trial Design

Outcomes

Khosravani 2009

Phase B 1.8 mg physostigmine as gel versus placebo

Crossover

Relief of dry lip & mouth symptoms & increase in salivary production for up to 3 hours in 1.8 mg physostigmine group. Results reported graphically.

Mean AUC value for salivary volume response 43.4 ± 9.4 vs 8.3 ± 6.6 (P < 0.001).

Unable to use these data for meta‐analysis.

Adverse Effects; 8 participants had mild gastrointestinal upsets and 1 had sweating

Taweechaisupapong 2006

Pilocarpine lozenges 3 or 5 mg or placebo. Patients had a single lozenge at each of 3 treatment sessions 10 days apart

Crossover

3 mg and 5 mg lozenge showed statistically significant improvement in oral dryness, and increase in saliva production compared to placebo (P </= 0.05). Maximum salivary output was 60 to 90 minutes post‐lozenge administration. No data were presented.

Speaking difficulty & sore mouth symptoms showed no statistically significant difference from placebo after a single dose.

No statistically significant difference in pulse and blood pressure.  No adverse effects reported with single doses.

Trial

Intervention

Trial Design

Outcomes

Blixt‐Johansen 1992

Mucin spray (Saliva Orthana) versus placebo

Parallel group trial in elderly patients in long term hospital care

At baseline patients had poor condition of oral mucosa. Condition of oral mucosa improved in both groups, but there was a much greater reduction in oral pathology in the mucin spray group. No data were presented.

No adverse effects noted. Suggested that increased attention on oral hygiene was beneficial.

Donatsky 1982

CMC spray versus spray base versus flavoured water

Crossover

No difference between CMC and spray base in effect on oral dryness or on patient preference. CMC spray was more effective than water on oral dryness and patients preferred the CMC spray to water. Data analysis did not account for crossover design.

No adverse effects noted.

Duxbury 1989

Mucin spray (Saliva Orthana) versus placebo versus water

Crossover

14/30 (46.6%) and 15/30 (50%) wished to continue use of Saliva Orthana and the spray base respectively. Crossover design not accounted for. The product preference score for both these groups was reported as statistically significantly greater than the water control (P = 0.043 and P = 0.049 respectively).

Kerr 2010

Mucoadhesive disk (carbomer homopolymer, triglycerides, glucose oxidase, lysozyme & lactoferrin plus flavour) versus placebo disk

Crossover

Overnight 'washout' between phases. Data presented graphically & no indication of adjustment for crossover design. Authors report likely carryover effect between treatment phases. No difference in oral dryness or salivary flow rates between active & placebo disks.

Persson 2007

Buffered 'prophylin' prophylactic gel versus unbuffered 'prophylin' gel versus water

Crossover

No difference between the interventions in effect on oral pH, salivary secretion rate & count of cariogenic bacteria or Candida sp. Data did not take account of crossover design. No adverse effects were detected.  Researchers experienced difficulty obtaining UWS measures from elderly participants.

van der Reijden 1996

Mucin spray (Saliva Orthana) versus polyacrylic acetate spray versus xanthum gum spray versus placebo

Crossover

Patients with Sjogren’s syndrome tried 4 sprays. None were completely effective. Patient preference for active versus placebo nearly attained statistical significance (Chi² 7.259 (df = 3); P = 0.064) and preference may have been related to underlying saliva flow rate. 15/43 patients expressed no desire to use any of the 4 sprays after the end of the trial. No adverse effects noted.

Trial

Intervention

Trial Design

Outcomes

Bjornstrom 1990

8 Treatments compared

* Ascoxal – chewable tablet

* Mucidan lozenge

* Salivin Lozenge (xanthum gum)

* V6 chewing Gum

* CMC mouthrinse

* Saliment (CMC) spray with xylitol

* Salisynt (CMC) spray with sorbitol

* Systemic nicotinamide

Crossover

106 participants instructed to use each product for 14 days with 1‐week washout between phases.  Only 55 used all 8 products. No usable data presented. All 8 products "relieved dry mouth & difficulty talking & swallowing to some extent." V6 chewing gum and Salivin lozenge were ranked as the two best products, but no product had a long‐term effect on SWS production.

No adverse effects reported but Oral Nicotinamide systemic treatment was withheld from participants with head & neck cancer due "possible risk of stimulating tumour growth".

Bots 2005

Gum versus Xialine spray

Crossover

10/49 (20%) preferred the xialine spray and 39/49 (80%) preferred the Freedent gum (Chi² 17.16 (df = 1); P < 0.001). This difference is statistically significant and reasons given for preference include effectiveness and taste.

Risheim 1993

Dentirol chewing gum (xylitol)

versus

Profylin lozenge (xylitol/sorbitol)

Crossover

2 sticks of gum up to 5 x daily versus 1 lozenge 4 to 8 x daily. Both products gave subjective dry mouth symptom relief in approximately 1/3 of participants but no change in SWS. Patients ranked gum & lozenge equal for preference. 

No adverse effects reported.

Trial

Interventions

Trial Design

Outcomes

Andersson 1995

CMC versus Salinum linseed oil spray

Crossover

Data did not account for crossover design. Text states that more patients experienced reduction in oral dryness when using Salinum linseed spray than when the CMC spray was used. More participants preferred the linseed oil spray. Paper states that both mean plaque and gingival indices were reduced during the Salinum period but gives incomplete comparative data.

No adverse effects reported.

Epstein 1999

Biotene oral Balance Gel & toothpaste versus placebo (CMC gel and regular toothpaste)

Crossover trial with some period effect so only first period data reported

Based on first period data authors report Biotene products "more effective than control (P = 0.04) and reduced dry mouth on waking (P = 0.05)"

Frost 2002

IntraOral device releasing Biotene Oral Balance gel versus usual care

Crossover

Median (IQR) treatment versus control.

Dryness 4 (2 to 4) versus 3 (2 to 4) (P = 0.056)

Speech 4 (2 to 5) versus 2 (2 to 5) (P = 0.003)

Swallowing 4 (2 to 5) versus 2.5 (2 to 4) (P = 0.031)

Patient preference was greater in the device group (66%) compared to control but data available were not suitable for meta‐analysis.

Furumoto 1998

CMC spray versus HCC spray versus HCC gel versus margarine

Crossover. Appropriate paired analysis and medians (IQR) reported as data distribution skewed

Median oral dryness score  after treatment (low score = less dry) on day 10 (IQR).

CMC spray 28.00 (3.06)

HCC spray 28.75 (2.23)

HCC gel 27.75 (3.62)

Margarine 29.25 (5.06)

Median Duration of Relief  ‐ minutes (IQR).

CMC spray 1.33 (0.61)

HCC spray 1.33 (1.25)

HCC gel 2.44 (0.90)

Margarine 1.39 (0.68)

Only HCC gel showed statistically significant improvement in oral dryness compared to baseline over 10 days of use (P < 0.05). HCC gel "rated better than margarine for convenience, perceived value, minutes of relief & overall rating. No other significant between group differences."

Gil‐Montoya 2008

Biotene Oral Balance mouthwash & gel versus mint flavoured water and CMC cream, used 3 to 4 x daily for 4 weeks

Pilot crossover

Results: "improvement in the need to drink liquids in order to swallow was greater in the study group during the first period, but smaller in the same group during the second period.....improvement in dry floor of mouth was greater in the placebo group during the first period, but smaller in the same group during the second period.....the number of patients that improved in their OHIP scores was paradoxically somewhat greater in the placebo group in both interventional periods."

Johansson 2001

Salinum (linseed) mouthwash versus Salinum + chlorhexidine

Crossover

Paired nature of data not accounted for in analysis. Both products resulted in improved oral dryness & chewing/swallowing & Salinum reduced speaking problems & burning mouth.

McMillan 2006

Oral Balance gel by oral device versus Oral Balance gel bolus

Crossover

Trial presented median ± IQR for the outcome of change in oral dryness (X Inventory & GOHAI) & UWS after treatment and found "no difference in oral dryness or flow rates between the 2 treatments". Likewise "there was no significant difference in change in oral microbial profile or generalized inflammation between the two treatments".

Momm 2005

Aloe vera gel versus CMC spray versus canola oil spray versus mucin spray

Crossover

At baseline mean xerostomia score (scale 1 to 6) was 4.5 ± 0.11. Post‐treatment mean xerostomia scores were 3.7 ± 0.11, 3.8 ± 0.12, 3.8 ± 0.12, 3.8 ± 0.11 for aloe vera, CMC, Canola oil and mucin respectively. P < 0.001 for comparison between baseline and post‐treatment mean, for all groups.

Mouly 2007b

Oxygenated glycerol triester (OGT) spray versus Saliveeze

Parallel group

Patient satisfaction concerning taste favoured OGT, mean difference of VAS score for taste 1.4 ± 0.6 P = 0.04. Overall mouth condition showed improvement in both groups & "no significant differences between the treatment groups were found".

Poland 1987

CMC/sorbitol swabs versus lemon glycerin swabs

Crossover

CMC sorbitol reported to be better than lemon glycerin. Incomplete data presented could not be included in meta‐analysis and the authors noted a period effect.

CMC/sorbitol also improved "dentition and gingival scores" though no data to support this were presented in the report. Patient preference favoured CMC/sorbitol (Chi² 10.89 (df = 1); P = 0.001).

Rantanen 2003

1% sodium lauryl sulphate (SLS) toothpaste versus 4% betaine (BET) toothpaste versus combined 1% SLS+4% BET toothpaste

Crossover trial with 6‐week washout periods between treatment phases when a reference toothpaste containing neither SLS nor betaine was used

Relief of oral dryness in xerostomic patients.

BET 44%

BET + SLS 22% (P = 0.002 compared to BET)

SLS 18% (P = 0.022 compared to BET)

Ref 7%  (P = 0.000 compared to BET)

No adverse effects reported.

Shahdad 2005

Biotene mouthcare system versus BioXtra mouthcare system

Crossover

Participants were asked 5 questions concerning the 'pleasance' of the products. BioXtra was rated statistically significantly better for pleasant taste of toothpaste, mouthwash and gel and there was no difference between the systems for mouth 'feel'. Xerostomia‐related QoL was assessed with a 15 item survey, and overall there was no difference between the 2 systems. This trial is likely to have inadequate statistical power to detect a difference.

Ship 2007

Xerostom system (betaine, olive oil and xylitol) versus usual care

Crossover

Evaluated 8 aspects of xerostomia and found statistically significant differences between control and Xerostom in overall mouth dryness (P = 0.038), overall tongue dryness (P = 0.002) and level of thirst (P = 0.0001) favouring Xerostom group. No data presented.

Shirodaria 2006

OASIS moisturising mouthwash versus experimental mouthwash

Crossover design: 3 days acclimatisation, 3 day treatment A, 3 day washout usual care, 3 day treatment B

Paper reports OASIS showed "statistically significant improvement over subject's normal remedies for managing dry mouth for strength of flavour, taste, freshening breath, immediate and long‐lasting lubrication and moisturization" based on 5 point rating scales, but no data were presented.

Trial

Interventions

Trial Design

Outcomes

Aagaard 1992

V6 gum versus mucin gum versus placebo gum

Crossover

"50% of participants had an increase in UWS from all products" and preference was for mucin gum (61%) V6 (21%) and placebo (5%). Unclear how many participants completed the trial & were included in the outcomes. No adverse effects were reported.

Olsson 1991

V6 gum versus PTC gum

Crossover single dose

Statistically significant interaction between treatment effect and period effect. Patients chewed the gums for 35 minutes and both gums showed an increase in saliva secretion that peaked 17.5 minutes after chewing started. No data were presented for each randomised group. No adverse effects were reported.

Tradename

Ingredients

Aldiamed

Aloe vera gel

Betaine Toothpaste

Trimethylglycine

Biotene Oral Balance

Lysozyme, lactoferrin, lactoperoxidase, salivary, enzyme‐protein

Bioxtra system

Xylitol, salivary enzymes and colostrum extract

Dentirol gum

Xylitol chewing gum

Freedent chewing gum

Sorbitol sweetened chewing gum

Glandosane

Carboxymethylcellulose, sorbitol and electrolytes

KY Jelly

Glycerin, hydroxyethylcellulose

MoiStir (MoiStik) swabs

Aqueous solution of electrolytes with sorbitol and sodium carboxymethylcellulose

Oasis Mouthwash

Glycerin, sorbitol, castor oil, carboxymethylcellulose

OGT spray

Oxygenated glycerol triesters

Oromoist mucoadhesive disk

Carbomer homopolymer, triglycerides, lemon favour, citric acid, glucose oxidase, lysozyme & lactoferrin

Carbopol spray

Polyacrylic acid polymer

Profylin Lozenges

Xylitol/sorbitol & carboxymethylcellulose

PTC Gum

Xylitol/sorbitol/mannitol chewing gum

Salinum

Linseed oil spray

Saliva medac

Mucin (porcine)

Saliva Orthana

Mucin, xylitol, minerals and salts

Saliveze Mouth spray

Aqueous solution of electrolytes

Sorbee lozenges

Sorbitol sweetened lemon lozenges

V6 Gum

Sorbitol and carbamide chewing gum

Xerostom mouthcare system

Betaine, olive oil, fluoride, calcium, xylitol, vitamin E, allantoin, vitamin B5, potassium

Xialine spray

Xanthan gum, fluoride, and sorbitol