Assessing the Efficacy of a Carbamide Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief

NCT06363955 | Completed DMC

• 2 other identifiers: UNIMOUTH750/13.02.2023
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy and safety of a carbamide peroxide 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. Carbamide peroxide breaks down to hydrogen peroxide and urea and shows antiseptic and antimicrobial properties and it might help with the parameters to be assessed. Participants randomly get the 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.

Conditions

Wound Heal; Oral Dryness; Postoperative Pain; Sjogren's Syndrome; Biopsy Wound; Mouth; Wound; Mouth Dryness; Dental Plaque; Gingival Inflammation

Keywords

Oral Wound Healing; Oral Biopsy; Postoperative Symptoms; Oral Hygiene; Mouthwash; Hydrogen Carbamide; Hydrogen Peroxide; Sjogren's Syndrome; Minor Salivary Glands Biopsy; Primary Intention Healing; Dental Plaque; Gingival Inflammation

Outcome Measures

Primary Outcomes (4)

• 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 carbamide peroxide mouthwash versus the placebo group.

  Day 14

• 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 carbamide peroxide mouthwash versus the placebo group.

  Day 14

• 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 carbamide peroxide mouthwash versus the placebo group.

  Day 7

• 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 carbamide peroxide mouthwash versus the placebo group.

  Day 7

Secondary Outcomes (11)

• Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home)

  Days 0, 1, 2, 3, 4, 5 and 6

• Postoperative symptoms (pain, eating and speech difficulty) on day 7

  Day 7

• Postoperative symptoms (pain, eating and speech difficulty) on day 14

  Day 14

• Wound healing based on the incision/wound length

  Days 0, 7 and 14

• Subjective oral dryness symptoms (8-item VAS questionnaire)

  Days 0, 7 and 14

Other Outcomes (3)

• Adverse Events

  Day 0, Day 7, Day 14

• Participant's comments and satisfaction regarding the provided treatment/use of the products

  Day 14

• Compliance

  Day 14

Study Arms (2)

Carbamide Peroxide Mouthwash

EXPERIMENTAL

A mouthwash containing carbamide proxide/hydrogen peroxide as active ingredient

Device: Carbamide Peroxide Mouthwash

Placebo

PLACEBO COMPARATOR

A mouthwash that looks, smells and tastes like the experinmental mouthwash without active ingredients

Device: Placebo mouthwash

Interventions

Carbamide Peroxide Mouthwash DEVICE

The experinmental mouthwah is a solution containing 4.3% w/v hydrogen carbamide, which breaks down to 1.51% w/v hydrogen peroxide, serving as the active ingredient. Participants rinse (swish and spit) with the mouthwash three times a day for one minute each time, using a 10ml quantity (as indicated by a marking line inside the bottle cap) for a total of 14 days, starting from day 0, i.e. the day of the biopsy (see procedure in the detailed description). Consumption of liquid or solid foods should be avoided for at least thirty minutes following each rinse. Participants are asked to maintain their usual oral hygiene routine. It is a Class IIa, CE-marked medical device made and distributed by Intermed S.A. and Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.

Also known as: Hydrogen Peroxide Mouthwash

Carbamide Peroxide Mouthwash

Placebo mouthwash DEVICE

Placebo mouthwash is a similar (look-and-taste-alike) solution to the experinmental mouthwash made by the same manufacturer, without active ingredients. Participants rinse (swish and spit) with the mouthwash three times a day for one minute each time, using a 10ml quantity (as indicated by a marking line inside the bottle cap) for a total of 14 days, starting from day 0, i.e. the day of the biopsy (see procedure in the detailed description). Consumption of liquid or solid foods should be avoided for at least thirty minutes following each rinse. Participants are asked to maintain their usual oral hygiene routine.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Patients requiring lower lip salivary gland biopsy for investigation of Sjögren's syndrome
• 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
• Able to use the study products (rinse - swish and spit)
• Agreeing to abstain from the use of any products for xerostomia other than the products provided by the study.
• 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.

You may not qualify if:

• Age \<18 years
• Total number of teeth in the oral cavity \<10
• Existence of orthodontic appliances
• Current use of bleaching trays
• Presence or history of oral malignant lesions
• 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)
• Currently undergoing and/or has received radiation therapy to the head or neck (including radioactive iodine therapy)
• Currently receiving or has received within the previous 12 months chemotherapy and/or targeted therapies for any malignancy
• History of acute myocardial infarction and/or vascular stroke during the last 6 months
• 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
• Use of antibiotics in the last 1 month prior to biopsy or conditions requiring antibiotic prophylaxis
• Use of any antimicrobial mouthwash in the last 1 month before the biopsy
• 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
• Use of sialagogues
• Heavy smokers (those who smoke greater than or equal to 25 cigarettes per day) and tobacco chewers or users of tobacco pouches

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.: collaborator

Study Sites (1)

Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens

Athens, Attica, 11527, Greece

Location

Related Publications (11)

• Fox PC. Simplified biopsy technique for labial minor salivary glands. Plast Reconstr Surg. 1985 Apr;75(4):592-3. doi: 10.1097/00006534-198504000-00029. No abstract available.

  PMID: 3983264 BACKGROUND

• 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.

  PMID: 7500245 BACKGROUND

• Pai S, Ghezzi EM, Ship JA. Development of a Visual Analogue Scale questionnaire for subjective assessment of salivary dysfunction. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Mar;91(3):311-6. doi: 10.1067/moe.2001.111551.

  PMID: 11250628 BACKGROUND

• Landry RGTR, Howley T. Effectiveness of benzydamine HCl in the treatment of periodontal post-surgical patients. Res Clinic Forums 1988;10:105-118.

  BACKGROUND

• 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.

  PMID: 14121956 BACKGROUND

• 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.

  PMID: 14158464 BACKGROUND

• Osailan SM, Pramanik R, Shirlaw P, Proctor GB, Challacombe SJ. Clinical assessment of oral dryness: development of a scoring system related to salivary flow and mucosal wetness. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Nov;114(5):597-603. doi: 10.1016/j.oooo.2012.05.009. Epub 2012 Sep 7.

  PMID: 22959491 BACKGROUND

• 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.

  PMID: 22244162 BACKGROUND

• Marini L, Rojas MA, Sahrmann P, Aghazada R, Pilloni A. Early Wound Healing Score: a system to evaluate the early healing of periodontal soft tissue wounds. J Periodontal Implant Sci. 2018 Oct 24;48(5):274-283. doi: 10.5051/jpis.2018.48.5.274. eCollection 2018 Oct.

  PMID: 30405935 BACKGROUND

• 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.

  PMID: 379049 BACKGROUND

• 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.

  PMID: 33178277 BACKGROUND

MeSH Terms

Conditions

Xerostomia; Pain, Postoperative; Sjogren's Syndrome; Wounds and Injuries; Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Dental Deposits; Tooth Diseases; Infections; Gingival Diseases; Periodontal Diseases

Study Officials

• Nikolaos Nikitakis, DDS, MD, PhD

  School of Dentistry, National and Kapodistrian University of Athens

  STUDY CHAIR

• Nikolaos Apostolidis, DDS

  School of Dentistry, National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Oral Medicine and Pathology and Hospital Dentistry, School of Dentistry and Dean, School of Dentistry

Model Details: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide mouthwash or placebo mouthwash, made by the same manufacturer.

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 12, 2024
• Study Start: April 25, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests will be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered.
• Access Criteria: Access to trial individual participant data (IPD) can be requested by qualified investigators whose proposed research has received Institutional Review Board (IRB) approval. Data will be available via a data repository following execution of data use agreement.

Locations

GR (1)