Subjects:
Twenty patients (9 females and 11 males) with severe hyposalivation due to radiation treatment for cancer in the head and neck.


Objective:
To compare the effects of Salinum and MAS-84 on oral mucous membrane flora in patients with severe hyposalivation following radiation treatment for cancer of the head and neck.


Methodology:

• The study was a 7-week crossover, single-blind study. Patients were randomly divided into two groups. One group used Salinum for 3 weeks and the other group used MAS-84, followed by a one-week washout period using water for saliva replacement, after which patients used the other treatment for 3 weeks. Patients were instructed to use the artificial saliva as needed.
• Microbial samples were harvested by scrapings from the oral mucosal membrane of the palate, tongue, and cheeks.

Findings:

• A high number of acid tolerant microorganisms (lactobacilli, mutans streptococci, and yeast) were found in samples collected from the mucous membranes, consistent with those observed in other patients with xerostomia.
• No significant differences were observed when comparing the baseline values with those reported after the two saliva substitutes were used.

Conclusions:
“This study suggests that use of the linseed extract (Salinum) and the carboxymethyl cellulose preparation (MAS-84) during periods of weeks does not influence the microbial populations related to caries or periodontitis or infections in the oral mucous membranes.”³⁰


Note:
This appears to be a substudy of the same group of patients described in Andersson et al, 1995.

Subjects:
Twenty patients (9 females, 11 males) with xerostomia who had been treated for cancer in the head and neck by radiation. Resting saliva flow was <1.5 mL in 15 min; flow stimulated by chewing was <3.5 mL in five minutes.


Objective:
Compare the effect of Salinum and a sodium carboxymethyl cellulose preparation (MAS-84) on symptoms of xerostomia: general feeling of dry mouth, difficulties in chewing and swallowing, taste disturbances, problems with speech, and mouth burning. Plaque index and gingival bleeding were also determined.


Methodology:

• The study was a 7-week cross-over, single-blind study. Patients were randomly divided into two groups and instructed to use the artificial saliva as needed. One group used Salinum for 3 weeks, and the other group used MAS-84. After a 1-week washout period using water for saliva replacement, patients switched to the other treatment for 3 weeks.
• Resting and stimulated saliva flow rates were determined at initial evaluation and at Week 4 (after washout).
• Subjective symptoms of dry mouth; burning sensations in the mucosa of the oral cavity, pharynx and esophagus; and impairment of taste, speech, chewing and swallowing were evaluated using a verbal rating scale for severity at Days 0, 7, and 21 of each treatment period.
• Condition of the oral mucosal membrane was observed; plaque and gingival bleeding indices were determined.

Findings:

• The general symptoms of dry mouth were reduced during both the period of Salinum use (P<0.001) and the period of MAS-84 use (P<0.01)
• Relief was significantly more pronounced during Salinum use.
• The chewing/swallowing (P<0.001), taste (P<0.01), speech disturbances (P<0.001), were significantly more reduced during the Salinum period.
• The reduction in plaque index (P<0.01) and gingival bleeding (P<0.001), were significant during the Salinum period compared to the MAS-84 period.
• There was no difference between preparations in effect on mouth burning.
• The average duration of the Salinum effect was 58 minutes compared to 31 minutes duration with the use of MAS-84. • On average patients used approximately three times more fluid volume of MAS-84 than Salinum.

Conclusions:
"[T]he results of the present study indicate that the linseed extract gives a significant reduction of the symptoms of dry mouth and that this effect increases with increasing time the saliva substitute is used.”

Subjects:
To test the effect of Salinum in patients with severe hyposalivation.


Objective:
To compare the effects of Salinum and MAS-84 on oral mucous membrane flora in patients with severe hyposalivation following radiation treatment for cancer of the head and neck.


Methodology:

• Patients were instructed to use the artificial saliva as needed over a period of seven days. The does of 2 mL was distributed around the oral cavity and then swallowed.
• Subjective symptoms of dry mouth; burning sensations in the mucosa of the oral
  cavity, pharynx and esophagus; and impairment of taste, speech, chewing and
  swallowing were evaluated by questionnaire at baseline and after 7 days of Salinum use. Symptoms were graded according to severity.
• Oral hygiene was determined by estimation of dental plaque after staining with disclosing solution.
• Gingival inflammation was estimated by presence of gingival bleeding on probing.

Findings:

• The general symptoms of dry mouth were reduced after 7 days of Salinum use in 27/37 patients (73%).
• Most patients experienced an improvement in chewing, swallowing, and burning sensation.
• The presence of plaque and gingival bleeding were reduced following 7 days of
  Salinum use.
• Swallowing the solution after it had been distributed in the oral cavity provided relief of symptoms in the pharynx and esophagus.
• The taste and consistency of Salinum were considered acceptable.

Conclusions:
“The relatively small volumes of linseed extract needed to reduce the symptoms of dry mouth give indirect evidence that the preparation actually replaced some functional aspects of the mucins.”

Subjects:
Twenty-two patients (20 females and 2 males) with Sjögren’s syndrome.


Objective:
To determine if adding chlorhexidine to a Salinum preparation changes antibacterial effects of chlorhexidine and/or negatively impacts oral mucosa.


Rationale:
Chlorhexidine is an effective anti-plaque agent used to treat hyposalivation. Use of chlorhexidine rinses, however, may compromise the lubricating effect of existent salivary flow and cause a burning sensation after rinsing.

Methodology:

• The study was a double-blind, cross-over design. Patients were randomly divided into two groups. For 3 weeks, one group used Salinum while the other group used Salinum plus chlorhexidine. Afterwards, both groups went through a 3-week washout period using water for saliva replacement before switching treatment rinses for the remaining 3 weeks. Patients using Salinum, were told to swallow the liquid after rinsing.
• Measurements were assessed by questionnaire at baseline and after each treatment period and included subjective symptoms of dry mouth: burning sensations in the oral cavity, pharynx and esophagus; impairment of taste, speech, chewing and swallowing; and time of day associated with maximum discomfort.
• Oral hygiene was estimated by measuring dental plaque after staining with disclosing solution. Gingival inflammation was estimated by evaluating gingival bleeding on probing. • Microbial samples were harvested by swabs from oral mucosa from the palate, tongue, and cheeks.

Findings:

• Subjective symptoms were significantly reduced following use of Salinum (P<0.05) and Salinum with chlorhexidine (P<0.001). Pretreatment chewing and swallowing problems, though minor, were reduced following both treatments.
• Mirror friction scores indicated oral mucosa lubrication after both treatments.
• Speaking problems were significantly reduced following use of Salinum (P<0.05) but not Salinum and chlorhexidine.
• Both treatments decreased reports of burning mouth sensation; the reduction was significant after use of Salinum (P<0.05).
• Plaque and gingivitis decreased after both treatments; Salinum plus chlorhexidine showed greater improvement for plaque but not gingivitis.

Conclusions:
“All patients reported relief from some of the symptoms of oral dryness and those with the most severe symptoms experienced the greatest effect. …use of Salinum and Salinum with chlorhexidine reduces symptoms of dry mouth, plaque, bleeding on probing and friction on the oral mucosal surfaces. Addition of chlorhexidine to Salinum does not seem to influence these positive effects and seems to retain its antibacterial effects.”

Subjects:
Saliva was collected from three healthy male donors.


Objective:
To determine viscosity and film-forming properties of saliva substitutes compared to human saliva and relate clinical efficacy for the saliva substitutes.


Methodology:

• Whole saliva was collected from three healthy male donors who had refrained from eating and drinking one hour prior to collection. Salivary secretion was stimulated by chewing a piece of Parafilm. A final volume of 18 mL was collected in glass tubes.
• Salivary viscosity, elasticity, surface tension, and protein concentration were measured.
• Adsorption/desorption at the solid/liquid interface and the film-forming qualities of the samples were also evaluated.

Findings:

• Saliva adsorbs in fairly equal amounts to both hydrophilic and hydrophobic surfaces, enabling protective functions of saliva to be applied to multiple surfaces in the oral cavity.
• MAS 84 did not show any film-forming capacity on hydrophilic surfaces (the model for the oral mucosa) and showed inadequate film-forming capacity on the hydrophobic surface.
• Salinum showed behavior similar to saliva with respect to the rate and degree of surface tension reduction.
• Saliva Orthana was most efficient in reducing tension at solid/liquid and air/liquid interfaces.

Conclusions:
“Both Saliva Orthana and Salinum, having viscosities exceeding that of whole saliva, possess in addition an important quality in common with saliva ─ the ability to form interfacial films at solid/liquid and air/liquid interfaces. The film-forming property seems to have a higher impact on the clinical efficacy of saliva substitutes than the viscosity alone.”

Subjects:
Sixteen patients (11 female and five male) who had undergone ileostomy operation and reported symptoms of xerostomia


Objective:
To test the safety associated with long-term use of Salistat


Methodology:

• After baseline measurements were assessed, patients were given sufficient Salistat for three months’ use and instructed to use the tablets when they experienced dryness of the mouth. Patients were told to return for additional supplies as needed.
• Stimulated salivary secretion rate, caries, buffering capacity, and salivary pH were evaluated at baseline and after 6 months. Salistat tablets were not taken on
  evaluation days.
• Presence of Streptococcus mutans and lactobacilli in the saliva, plaque index, and plaque formation were evaluated in 8 patients.

Findings:

• At 6 months, none of the patients developed new dental erosions.
• There were no changes in buffering capacity and salivary pH from start to end of trial.
• No significant changes were seen in presence of S mutans or lactobacilli, plaque index, or plaque formation rate during the trial.
• Patients considered the taste, form, and tablet size of Salistat to be good.

Conclusions:
“The results of the present clinical pilot study indicate that Salistat is a safe and efficacious long-term treatment for dryness of the mouth. No side effects could be seen after six months’ use.”

Subjects:
Seventeen patients (16 female, 1 male) with significant dryness of the mouth due to rheumatic disease, Sjögren’s syndrome, medication, or a combination of medication and rheumatic disease


Objective:
Test the effect of Salistat for subjective problems associated with xerostomia


Methodology:

• Patients were allowed unrestricted use of Salistat tablets for one week.
• Patients made subjective assessments using visual analogue scales at baseline, Day 3, and Day 7.
• Use of tablets was recorded during the trial.

Findings:

• Patient assessment of discomfort due to dry mouth improved significantly at Day 3 (P<0.04) and Day 7 (P<0.001).
• Fifteen of 17 patients judged the tablet “good” or “very good.”
• Two patients reported adverse events (burning feeling in the mouth and acid stomach), but both reported marked improvement in dry mouth symptoms.
• Most patients (75%) used 7 or fewer tablets per day.

Conclusions:
“Our experience in treating patients with Salistat for dryness of the mouth is good. Stimulating the patient’s own salivary glands into production when possible works to better advantage than using saliva substitutes.”

Subjects:
Ten female patients with low salivary secretion and dry mouth


Objective:
Test effects of Salistat on salivary secretion and tooth enamel


Methodology:

• Patients took one Salistat tablet every 30 minutes from 8:30 am to 4:00 pm (16 tablets per day).
• Patients placed an enamel test piece in the mouth from 8:30 am to 4:00 pm (except during meals) and were instructed to move the test piece around the mouth. Patients removed the test piece at 4:30 pm and kept it moist with damp cotton wool until returning it for testing (by 5:00 pm).
• Micro-hardness of the tooth enamel was tested using a Knoop hardness meter. The average of three values was recorded for each measurement.
• Saliva secretion was stimulated by chewing and sucking on tablets and collected. Parotid saliva was pooled from both glands and evaluated to determine rate of secretion, buffer capacity, and phosphate and calcium levels.

Findings:

• There was no significant difference in the micro-hardness of tooth enamel before and after use of tablets.
• Secretion rates were appreciably higher for tablet stimulation compared to chewing stimulation.
• All but one patient, who lacked all taste sensation, found Salistat effective.

Conclusions:
"Use of 16 Salistat tablets in one day significantly stimulated saliva secretion and relief from symptoms of dry mouth, without softening tooth enamel. Electrolyte content of the tablet is probably the most important factor in preventing minerals from dissolving from tooth enamel.