Xerostomia in Dialysis Patients—Oral Care to Reduce Hyposalivation, Dental Biofilms and Gingivitis in Patients with Terminal Renal Insufficiency: A Randomized Clinical Study
Round 1
Reviewer 1 Report
I congratulate the authors for the work done, the subject matter of the study has its relevance and deserves further investigation.
I suggest just a few revisions.
I would avoid including the term Handicap in the text (it is no longer a term that is used specifically in scientific literature), replace it with disability.
In the introduction the quotation in line 63 is missing and verify the correctness of the quotation in line 65.
In the M&Ms, to better follow the progression of the interventions, I suggest marking the interventions with T0-T1 etc..
In table 1 highlight the significant results.
They miss the limitations of the study such as the number of samples and the reduced intervention time interval that have been highlighted and justified in the discussions.
Author Response
Thank you for he review. We will replace the term Handicap by Disability. The quotations in Introduction will be corrected, timeline T0 - T1 will be used, and the significances in the Table 1 will be marked.
Thank you again,
Peter Gaengler
Reviewer 2 Report
General comments:
Egbring et al conducted a randomized controlled trial, and the aim of this study is to investigate whether using oral care gel and nursing toothbrushes for daily oral hygiene (the verum group) is better than the control group (conventional dentifrice and toothbrushes) in patient on dialysis patients. Their result showed that there was significantly reduced frequency of dry mouth, decreased Silness and Löe plaque index as well as number of gingivitis teeth and periodontitis teeth in the verum group compared to baseline. In addition, the verum group showed slightly positive impact on oral health-related quality of life (OHIP-14). The study concluded that using oral care gel and nursing toothbrushes showed a beneficial effect on xerostomia, oral health and quality of life in dialysis patients. However, the study method is not clear and well designed, and there are several issues to be addressed.
Major comment:
1. At the baseline, there was a statistically significant difference between the two groups in the frequency of dry mouth (p<0.05). Is any selection bias existing?
2. Based on the study’s design, a common concern in open-label trials is patient-reported outcomes. This study’s outcomes focus on dry mouth frequency and whether feeling dry mouth during dialysis. However, both are subjective assessment which might be overly optimistic” in the investigation arm and “overly pessimistic” in the control arm. The author should mention in the Discussion section.
3. Is there any inclusion or exclusion criteria for this study? A diagram figure will be better to show the enrolled patients.
4. The study group is relative too small, and this study did not provide patients’ characteristics and underlying diseases. The dialysis condition for enrolled patients such frequency dialysis, ultrafiltration volume.. etc are not clear.
5. Is there any other side effect or safety concern for the verum group? Please report it.
Minor comment
1. Figures lacks clear background and presentation, such as standard deviation or statistical P value.
2. There are typing errors throughout then manuscript that should be correct. Such as quality of life, not quality of live.
3. Line:180: The value of the dental plaque index SLI, the number of gingivitis teeth, denture hygiene index (DHI) and the mandibular DHI of verum group at the intermediate examination are not shown in Table 1.
4. The abstract is not well organized.
Author Response
Major 1. There is no bias, this is the result of randomization, however in "favour" of the control group. 2. We will mention the subjective assessment in the Discussion. 3. All patients in the Dialysis center werde invited to take part, however, only the subjects included gave consent because of the psychologically vulnerable situation of dialysis patients. 4. See 3. 5. There were no side effects including AE or SAE in both groups.
Minor 1. Figurs will be updated. 2. Typing errors corrected. 3. Index values will be shown in Table 1. 4. Abstract will e better organized.
Thank you again,
Peter Gaengler
Reviewer 3 Report
This is a very simple randomized controlled trial of patients with maintenance hemodialysis. The authors observed the oral status of participants assigned to the oral care intervention group taking ORIFAN or the conventional care group after 4 weeks. However, it seems that both the results and the graphs show the changes within treatment groups, making comparisons between groups are not shown.
<Major>
1. The authors describe the basis for calculating the sample size in method part, but detail of description is insufficient. It is necessary to describe clearly what the primary endpoint is and how much difference is expected to be detected in the calculation.
2. In the method part, is the significance level one-sided or two-sided?
3. There seems to be no information on the background at baseline of participants of this study. Please provide a background table for the 44 participants, referring to other randomized trials.
<Minor>
1. In Table 1, the decimal point in the p-values for the before/after comparison of the tongue coating in the control group should be the same as in the other tables.
Author Response
Thank you for the review.
Major 1. The sample size is the result of consented subjects out of > 100 Patients in the Dialysis Center, because of their psychological vulnerability. 2. The significance level will be desriped in detail. 3. See 1.
Minor 1. Table 1 will be corrected.
Thank you again,
Peter Gaengler
Round 2
Reviewer 2 Report
The authors response well according to my comments.
Reviewer 3 Report
The manuscript has been revised well.
