Postoperative Pain Clinical Trial
Official title:
A Randomized Placebo-Controlled Clinical Trial Assessing the Efficacy of a Hydrogen Peroxide Mouthwash (UNISEPT® MOUTHWASH) for Oral Wound Healing, Postoperative Symptoms, Xerostomia Relief, and Oral Hygiene Following Diagnostic Biopsy of Minor Labial Salivary Glands for Sjögren's Syndrome Investigation
Verified date | April 2024 |
Source | National and Kapodistrian University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the efficacy and safety of a hydrogen carbamide/peroxide mouthwash, named UNISEPT® MOUTHWASH, regarding oral wound healing, postoperative symptoms, xerostomia (dry mouth) and oral hygiene improvement. Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögren's Syndrome, following consultation with their rheumatologist. This is a standardized diagnostic procedure that leads to healing by primary intention (i.e. wound edges are closely re-approximated with sutures). Researchers are comparing this mouthwash with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving dry mouth and/or oral hygiene. Participants randomly get the hydrogen carbamide/peroxide mouthwash or the placebo one to use for 14 days after the biopsy. The investigators will not know which one they are providing as the bottles will be identical. Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation), improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial consultation and the biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (such as measuring saliva) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed.
Status | Completed |
Enrollment | 54 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria 1. Age >18 years 2. Patients requiring lower lip salivary gland biopsy for investigation of Sjögren's syndrome 3. Patients with subjective dry mouth, i.e. who have recorded =30mm in at least one of the first 4 questions of the VAS (Visual Analogue Scale) questionnaire according to Pai et al, 2001 4. Able to use the study products (rinse - swish and spit) 5. Agreeing to abstain from the use of any products for xerostomia other than the products provided by the study. 6. Patients who are legally competent and able to understand the information about the study, have been informed of the nature, scope and utility of the study, voluntarily agree to participate and have signed the consent form. Exclusion criteria 1. Age <18 years 2. Total number of teeth in the oral cavity <10 3. Existence of orthodontic appliances 4. Current use of bleaching trays 5. Presence or history of oral malignant lesions 6. Existence of viral or other infections of the oral cavity or pathology that could interfere with the primary outcomes of the study (e.g. oral vesicobullous disorders) 7. Currently undergoing and/or has received radiation therapy to the head or neck (including radioactive iodine therapy) 8. Currently receiving or has received within the previous 12 months chemotherapy and/or targeted therapies for any malignancy 9. History of acute myocardial infarction and/or vascular stroke during the last 6 months 10. Patients with poor glycemic control (HbA1c = 7% within the previous 3 months according to American Diabetes Association (ADA) recommendations), uncontrolled type I or II diabetes mellitus or other systemic diseases known to affect oral wound healing 11. Use of antibiotics in the last 1 month prior to biopsy or conditions requiring antibiotic prophylaxis 12. Use of any antimicrobial mouthwash in the last 1 month before the biopsy 13. Concurrent immunocompromised status and/or use of immunosuppressant medications (e.g. corticosteroids) and steroid inhalers or nasal sprays within the last 1 month prior to enrollment 14. Use of sialagogues 15. Heavy smokers (those who smoke greater than or equal to 25 cigarettes per day) and tobacco chewers or users of tobacco pouches 16. Received dental treatment during the period included in the study 17. Malnutrition 18. Alcohol abuse and (illicit) drug use disorders 19. Pregnancy or lactation/nursing/breast feeding 20. Known allergy to any of the ingredients of the study products 21. Inability to provide informed consent 22. Participation in another study of an investigational product or device until the primary endpoint is met 23. Other medical condition that, in the opinion of the investigator, may be causing the patient's non-compliance with the clinical investigation plan or confusion in interpreting the data |
Country | Name | City | State |
---|---|---|---|
Greece | Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
National and Kapodistrian University of Athens | Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. |
Greece,
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Papagiannopoulou V, Oulis CJ, Papaioannou W, Antonogeorgos G, Yfantopoulos J. Validation of a Greek version of the oral health impact profile (OHIP-14) for use among adults. Health Qual Life Outcomes. 2012 Jan 14;10:7. doi: 10.1186/1477-7525-10-7. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | Adverse events will be recorded at every visit. | Day 0, Day 7, Day 14 | |
Other | Participant's comments and satisfaction regarding the provided treatment/use of the products | Participants are provided with a 12-item questionnaire to complete during their visit on day 14. Eight of these questions pertain to the improvement in breath odor, taste, gum health, the sensation of mouth cleanliness and freshness, as well as the reduction in gum bleeding, ease of product use, and satisfaction level resulting from product use. These are scored on a four-point Likert scale: 'not at all' (score 1), 'slightly' (score 2), 'very' (score 3), and 'extremely' (score 4). Three questions require a 'Yes' or 'No' response, inquiring whether participants would reuse the product in the event of an oral wound or ulcer, for moisturizing the oral cavity and improving dry mouth, and if they would recommend the product. Lastly, one question addressing compliance will be answered using a four-point Likert scale: 0-2 (score 1), 3-5 (score 2), 6-8 (score 3), and 9+ (score 4). Results will be shown for each group and comparative analyses will be conducted between the two groups. | Day 14 | |
Other | Compliance | All patients are instructed to return the two initially provided bottles after use to record the remaining quantity. Compliance is further assessed through a question included in the aforementioned questionnaire, specifically addressing missed doses, answered on a four-point Likert scale: 0-2 (score 1), 3-5 (score 2), 6-8 (score 3), and 9+ (score 4). | Day 14 | |
Primary | Assessment of wound healing based on the modified Landry Healing Index on day 14 | Healing will be measured clinically using specific scores. The modified Landry Healing Index consists of the assessment of 5 clinical parameters (tissue color, bleeding on palpation, presence of granulation tissue, presence of suppuration, and healing of the surgical margin). As the initial index referred to gingival healing, it was slightly modified as in other studies, so that it refers to oral mucosal healing. The index values range from 1 to 5, where 1 corresponds to "very poor healing" and 5 to "excellent healing". Comparisons will be made between the UNISEPT® MOUTHWASH versus the placebo group. | Day 14 | |
Primary | Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14 | Healing will be measured clinically using specific scores. The EHS is composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of haemostasis (CSH), and clinical signs of inflammation (CSI). Zero, 3, 4 or 6 points are used to evaluate CSR (modified by adding point 4), whereas 0, 1, or 2 points are used for CSH and CSI. The EHS is generated by the summation of the points of these 3 parameters. The EHS for ideal wound healing is 10 points, while the worst possible score is 0 points. Comparisons will be made between the UNISEPT® MOUTHWASH versus the placebo group. | Day 14 | |
Primary | Assessment of wound healing based on the modified Landry Healing Index on day 7 | Healing will be measured clinically using specific scores. The modified Landry Healing Index consists of the assessment of 5 clinical parameters (tissue color, bleeding on palpation, presence of granulation tissue, presence of suppuration, and healing of the surgical margin). As the initial index referred to gingival healing, it was slightly modified as in other studies, so that it refers to oral mucosal healing. The index values range from 1 to 5, where 1 corresponds to "very poor healing" and 5 to "excellent healing". Comparisons will be made between the UNISEPT® MOUTHWASH versus the placebo group. | Day 7 | |
Primary | Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 7 | Healing will be measured clinically using specific scores. The EHS is composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of haemostasis (CSH), and clinical signs of inflammation (CSI). Zero, 3, 4 or 6 points are used to evaluate CSR (modified by adding point 4), whereas 0, 1, or 2 points are used for CSH and CSI. The EHS is generated by the summation of the points of these 3 parameters. The EHS for ideal wound healing is 10 points, while the worst possible score is 0 points. Comparisons will be made between the UNISEPT® MOUTHWASH versus the placebo group. | Day 7 | |
Secondary | Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home) | Participants will be given a pain diary (PD) to complete at home daily at the end of the day, from day 0 to day 6, with instructions for its completion. Specifically, the participants will record: the greatest intensity of the postoperative pain, as perceived (Numerical and Visual Scale, ranked 0-10), difficulty in eating (Yes/No), difficulty in speaking (Yes/No) and whether any analgesic treatment, apart from the one recommended for day 0, has been necessary (No or Yes: Which one?). Comparisons will be made between the two groups for every day from day 0 to day 6. | Days 0, 1, 2, 3, 4, 5 and 6 | |
Secondary | Postoperative symptoms (pain, eating and speech difficulty) on day 7 | During the visit in day 7, participants will be asked to record: the greatest intensity of the postoperative pain, as perceived (Numerical and Visual Scale, ranked 0-10), difficulty in eating (Yes/No), difficulty in speaking (Yes/No) and whether any analgesic treatment has been necessary (No or Yes: Which one?). Comparisons will be made between the two groups. | Day 7 | |
Secondary | Postoperative symptoms (pain, eating and speech difficulty) on day 14 | During the visit in day 14, participants will be asked to record: the greatest intensity of the postoperative pain, as perceived (Numerical and Visual Scale, 0-10), difficulty in eating (Yes/No), difficulty in speaking (Yes/No) and whether any analgesic treatment has been necessary (No or Yes: Which one?). Comparisons will be made between the two groups. | Day 14 | |
Secondary | Wound healing based on the incision/wound length | The incision/wound length will be measured in milimeters (mm) during every visit using a UNC 15 (North Carolina) periodontal probe. Standardized pictures will be also taken with an angulation perpendicular to the wound. The same periodontal probe will be placed by the wound as a reference scale. Comparisons will be made between the two groups (mean changes from day 7 to 0, day 14 to 0 and day 14 to 7). | Days 0, 7 and 14 | |
Secondary | Subjective oral dryness symptoms (8-item VAS questionnaire) | During all the visits, patients complete a 8-item 100 mm Visual Analog Scale (VAS) questionnaire developed by Pai et al, 2001 for subjective scoring xerostomia symptoms, namely: difficulty in speaking due to dryness, difficulty in swallowing due to dryness (0 mm: not difficult at all, 100 mm: very difficult), rating the amount of saliva in the mouth (0 mm: a lot, 100 mm: none), level of dryness in the mouth, the throat, the lips and the tongue (0 mm: not dry at all, 100 mm: very dry) and the level of thirst (0 mm: not thirsty at all, 100 mm: very thirsty). Comparisons will be made for each item of the questionnaire between the two groups by calculating the changes from day 7 to 0, day 14 to 0 and day 14 to 7. Higher values of the changes represent a better outcome. | Days 0, 7 and 14 | |
Secondary | Observed (objective) signs of oral dryness | During the clinical exam in each visit, Clinical Oral Dryness Score (CODS) is conducted, which assesses ten key features of dry mouth and allocates one point for each feature. The total score ranges from 0 to 10, with higher scores indicating more severe dry mouth. Comparisons will be made between the two groups on days 7 and 14. | Days 0, 7 and 14 | |
Secondary | Change in Unstimulated Saliva Flow Rate | Unstimulated whole saliva is collected in a cap over a 5-minute time period at around the same time of the day on days 0 and 14 and the volume is measured. The Unstimulated Saliva Flow Rate is measured in ml per minute and the change is calculated by subtracting the measurement at day 0 from the measurement at 14 days. Comparisons will be made between the two groups. | Days 0 and 14 | |
Secondary | Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index | The Plaque Index (PI) by Silness & Loe 1964 is a score of 0-3 with higher scores indicating greater plaque accumulation. A UNC 15 periodontal probe is used. Every tooth is evaluated at 4 sites (mesiobuccal, mid-buccal, distobuccal, and lingual) as 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth, which may be seen by using the probe or disclosing solution on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
The calculation of the full mouth index refers to the sum of the measurements on the 4 surfaces of all the teeth examined divided by four and then by the number of teeth examined. The final score ranges from 0-3. Full mouth PI is measured in all visits and comparisons will be made between the two groups on day 7 and 14. |
Days 0, 7 and 14 | |
Secondary | Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index | The Gingival Index (GI) by Loe & Silness 1963 scores from 0 to 3, with higher scores indicating greater inflammation. The examination is performed by sliding the periodontal probe (UNC 15) on the free gums (modification according to Löe - 1967) on all existing teeth of the person. Every tooth is evaluated at 4 surfaces (mesiobuccal, mid-buccal, distobuccal, and lingual). By dividing the sum of the values by 4, the gingival index of the tooth is calculated. The full mouth gingival index is obtained by summing the indices of each tooth divided by the total number of teeth examined. The overall index score, representing inflammation, is rated as mild (mean 0,1-1,0), moderate (1,1-2,0) and severe (2,1-3). Comparisons of the full mouth GI scores will be made between the 2 groups on day 7 and 14. | Days 0, 7 and 14 | |
Secondary | Oral Health Related Quality of Life | The Oral Health Impact Profile-14 (OHIP-14) scale is used to measure the participants' oral health related quality of life (OHRQoL) after the procedure. It has seven conceptualized domains (two items per domain - 14 total): functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Participants are asked to rate how frequently they experienced an oral health impact (as described by each item), scoring on a five-point Likert scale: never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4). Thus, OHIP-14 scores can range from 0 to 56. A high total value indicates a high negative impact on the OHRQoL. Comparisons will be made between the two groups on day 14. | Day 14 | |
Secondary | Assessment of swelling in the biopsy area | The existence of swelling in the biopsy area is assessed via a Yes/No question ("Is there swelling in the biopsy area?") during visits on day 7 and 14. Comparisons will be made between the two groups. | Day 7 and 14 |
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