Quality of Life Clinical Trial
Official title:
A Randomized Placebo-Controlled Clinical Trial Assessing the Efficacy of a Hydrogen Peroxide Gel (UNISEPT®ORAL GEL) for Oral Wound Healing, Postoperative Symptoms and Oral Hygiene in Patients Undergoing Incisional or Excisional Punch Biopsy of Gingival or Palatal Oral Mucosa
Verified date | April 2024 |
Source | National and Kapodistrian University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to assess the effectiveness and safety of a hydrogen carbamide/peroxide gel, called UNISEPT® ORAL GEL, in promoting oral wound healing, alleviating postoperative symptoms, and enhancing oral hygiene. Study participants will include individuals with any suspicious lesion in their gums or the roof of their mouth. They will undergo a procedure to remove a small piece of tissue for testing (biopsy) in order to confirm the diagnosis.This is a standardized diagnostic procedure that involves the use of a punch, which is a plastic handpiece with a cylindrical cutting blade. Subsequently, the wound heals naturally without the need for sutures. Researchers are comparing this gel 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 oral hygiene. Participants randomly get the hydrogen carbamide/peroxide gel or the placebo one to use for 14 days after the biopsy. The researchers will not know which one they are providing as the gel tubes will be identical. Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation) 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 biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (taking a photo the site of the biopsy) 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 | December 27, 2023 |
Est. primary completion date | December 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age >18 years 2. Patients requiring incisional or excisional biopsy in the gingiva or palate 3. 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 selected sextant <2 3. Existence of orthodontic appliances 4. Presence or history of oral malignant lesions 5. Existence of viral or other infections of the oral cavity, that could interfere with the primary outcomes of the study 6. Currently undergoing and/or has received radiation therapy to the head or neck 7. Currently receiving or has received within the previous 12 months chemotherapy and/or targeted therapies for any malignancy 8. History of acute myocardial infarction and/or vascular stroke during the last 6 months 9. 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 10. Use of antibiotics in the last 1 month prior to biopsy or conditions requiring antibiotic prophylaxis 11. Use of any antimicrobial mouthwash in the last 1 month before the biopsy 12. 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 13. Malnutrition 14. Alcohol abuse and (illicit) drug use disorders 15. Pregnancy or lactation/nursing/breast feeding 16. Known allergy to any of the ingredients of the study products 17. Inability to provide informed consent 18. Participation in another study of an investigational product or device until the primary endpoint is met 19. 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 | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
National and Kapodistrian University of Athens | Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. |
Greece,
LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available. — View Citation
Lopez-Jornet P, Camacho-Alonso F, Martinez-Canovas A. Clinical evaluation of polyvinylpyrrolidone sodium hyaluronate gel and 0.2% chlorhexidine gel for pain after oral mucosa biopsy: a preliminary study. J Oral Maxillofac Surg. 2010 Sep;68(9):2159-63. doi: 10.1016/j.joms.2009.09.047. Epub 2010 Jun 11. — View Citation
Marshall MV, Cancro LP, Fischman SL. Hydrogen peroxide: a review of its use in dentistry. J Periodontol. 1995 Sep;66(9):786-96. doi: 10.1902/jop.1995.66.9.786. — View Citation
Muniz FWMG, Cavagni J, Langa GPJ, Stewart B, Malheiros Z, Rosing CK. A Systematic Review of the Effect of Oral Rinsing with H2O2 on Clinical and Microbiological Parameters Related to Plaque, Gingivitis, and Microbes. Int J Dent. 2020 Oct 31;2020:8841722. doi: 10.1155/2020/8841722. eCollection 2020. — View Citation
Palaia G, Tenore G, Tribolati L, Russo C, Gaimari G, Del Vecchio A, Romeo U. Evaluation of wound healing and postoperative pain after oral mucosa laser biopsy with the aid of compound with chlorhexidine and sodium hyaluronate: a randomized double blind clinical trial. Clin Oral Investig. 2019 Aug;23(8):3141-3151. doi: 10.1007/s00784-018-2735-0. Epub 2018 Oct 30. — View Citation
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
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available. — View Citation
Wennstrom J, Lindhe J. Effect of hydrogen peroxide on developing plaque and gingivitis in man. J Clin Periodontol. 1979 Apr;6(2):115-30. doi: 10.1111/j.1600-051x.1979.tb02190.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | Adverse events will be recorded at every visit. | Day 0,7 and 14 | |
Other | Participant's comments and satisfaction regarding the provided treatment/use of the products | Participants are provided with a 10-item questionnaire to complete during their visit on day 14. Seven 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). Two questions require a 'Yes' or 'No' response, inquiring whether participants would reuse the product in the event of an oral wound or ulcer 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 initially provided tube 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 Percentage Healing Index on day 14 | The Percentage Healing Index (PHI) is calculated based on three distinct values: the wound area at T0 and T2.These values are acquired through standardized pictures taken immediately after biopsy (T0) and 14 days post-biopsy (T2), with the aid of a UNC 15 (North Carolina) periodontal probe, acting as a calibrator, that was placed alongside the treated area.The images obtained are processed using software (Image J, developed by Wayne Rasband and contributors at the National Institutes of Health, USA), capable of calculating the area in square millimeters (mm).
Initially, the T2 area is divided by the T0 area, and the result is multiplied by 100. The resulting value, known as the percentage unhealed index (PUI), indicates the percentage of the lesion that remained unhealed. The complementary value to this percentage is defined as the PHI at T2. Comparisons will be made between the UNISEPT® ORAL GEL versus the placebo group. |
Day 14 | |
Primary | Assessment of wound healing based on Percentage Healing Index on day 7 | The Percentage Healing Index (PHI) is calculated based on three distinct values: the wound area at T0 and T1.These values are acquired through digital photographs taken immediately after biopsy (T0) and at 7 days post-biopsy (T1), with the aid of a periodontal probe, acting as a calibrator, that was placed alongside the treated area.The images obtained are processed using software (Image J, developed by Wayne Rasband and contributors at the National Institutes of Health, USA), capable of calculating the area in square millimeters.
Initially, the T1 area is divided by the T0 area, and the result is multiplied by 100.The resulting value, known as the percentage unhealed index (PUI), indicates the percentage of the lesion that remained unhealed. The complementary value to this percentage is defined as the PHI at T1. Comparisons will be made between the UNISEPT® ORAL GEL 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 clinical signs | The researcher will record the following clinical signs after a clinical examination: redness of the biopsy area compared to the adjacent healthy tissue, presence of swelling, pus discharge, and bleeding upon palpation (Yes/No) | Days 7 and 14 | |
Secondary | Oral Hygiene - Dental Plaque: Sextant 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 index refers to the sum of the measurements on the 4 surfaces of the selected sextant examined divided by four and then by the number of teeth examined. The final score ranges from 0-3. 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: Sextant 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 selected sextant 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 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 |
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