Wound HealNCT06363955

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

A study testing Carbamide Peroxide Mouthwash in people with Wound Heal and Oral Dryness, run by National and Kapodistrian University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Wound Heal, Oral Dryness, Postoperative Pain
What is being tested?: Carbamide Peroxide Mouthwash
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteGreece
Study dates: 25 Apr 2023to 1 Apr 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Show all 23Show fewer

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
Received dental treatment during the period included in the study
Malnutrition
Alcohol abuse and (illicit) drug use disorders
Pregnancy or lactation/nursing/breast feeding
Known allergy to any of the ingredients of the study products
Inability to provide informed consent
Participation in another study of an investigational product or device until the primary endpoint is met
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

Trial locations and contacts

1 site in 1 country.

Greece1 site

Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens
Athens, Attica, 11527

Other trials in Greece

About this study

Official title: A Randomized Placebo-Controlled Clinical Trial Assessing the Efficacy of a Carbamide Peroxide 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

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.

Read the detailed description

This is a prospective, randomized, triple-blind, placebo-controlled clinical trial and post-market clinical follow-up (PMCF) study, expected to last approximately 12 months. All procedures/visits/examinations are taking place in the Oral Medicine and Pathology Clinic at the School of Dentistry, National and Kapodistrian University of Athens, Greece. Participants with reported dry mouth 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. After checking if they comply with the study's criteria, they are informed about the study and the biopsy procedure (including possible complications) and they sign the Ιnformed Consent Form.

All biopsies are obtained from the lower lip with a 12 - 15 mm linear incision. After blunt dissection of the borders, 5-7 lobules of minor salivary glands are removed by dissection with the scalpel or a curved mosquito forceps and the use of tweezers. Attention is paid not to injure nerve branches or vessels. Adequate hemostasis is achieved by manual pressure, and the incision is closed by simple interrupted non-absorbable 4/0 silk sutures at equal distances. Participants are instructed to have cold, soft diet for the day and use ice packs externally for 1-2 hours after the procedure. Use of 500mg paracetamol up to 3 times is permitted for day 0. Following their normal oral hygiene routine (brushing and toothpaste) is suggested.

Subsequently, they are assigned randomly in a 1:1 ratio to receive either a carbamide peroxide mouthwash or a placebo comparator, i.e. a look-alike substance that lacks active ingredients. Both participants and investigators are masked. Follow-up examinations are conducted at 7 and 14 days. On day 7 the sutures are cut.

The evaluation includes:

oral wound healing (primary intention) assessed by scores (primary outcome) and secondarily:
oral wound healing via measuring the incision/wound length
postoperative symptoms (such as pain, eating and speech difficulties)
quality of life assessed by a questionnaire
improvement of dry mouth through subjective and objective measurements
oral hygiene via plaque and gingival indices.

All data are anonymized and the outcome assessors are masked.

The mouthwash used in the experinmental/test group is a Class IIa, CE-marked (Conformité Européenne) medical device. This mouthwash contains hydrogen carbamide that breaks down to hydrogen peroxide and urea. Hydrogen peroxide has antiseptic and antimicrobial properties, as well the ability to mechanically clean affected areas by producing an oxygenated foam, while urea shares antiseptic and antimicrobial abilities as well and can enhance the pH of the oral cavity. These substances have been used in wound healing either in skin or intraorally, as well as in oral hygiene for a long time. However, to date, no clinical trial examining the use of a hydrogen carbamide/peroxide product in oral wound healing, postoperative symptoms or dry mouth has been reported. Published clinical studies on the control of dental plaque and periodontal inflammation exhibit partially conflicting results.

Conditions: Wound Heal, Oral Dryness, Postoperative Pain, Sjogren's Syndrome, Biopsy Wound, Mouth; Wound
Being tested: Carbamide Peroxide Mouthwash, Placebo mouthwash
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
Medical subject headings: Xerostomia, Pain, Postoperative, Sjogren's Syndrome, Wounds and Injuries, Dental Plaque, Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carbamide Peroxide MouthwashDevice
Also called Hydrogen Peroxide Mouthwash
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.
Placebo mouthwashDevice
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.

Study groups in NCT06363955
Study group	Role	What they receive
Carbamide Peroxide Mouthwash	Experimental	A mouthwash containing carbamide proxide/hydrogen peroxide as active ingredient Receives: Device: Carbamide Peroxide Mouthwash
Placebo	Placebo comparator	A mouthwash that looks, smells and tastes like the experinmental mouthwash without active ingredients Receives: Device: Placebo mouthwash

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7

Secondary outcomes (11)

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.
Measured: Days 0, 1, 2, 3, 4, 5 and 6
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.
Measured: Day 7
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.
Measured: Day 14
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).
Measured: Days 0, 7 and 14
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.
Measured: Days 0, 7 and 14
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.
Measured: Days 0, 7 and 14
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.
Measured: Days 0 and 14
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. Every tooth is evaluated with a UNC 15 periodontal probe 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, 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 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 (mean changes from baseline).
Measured: Days 0, 7 and 14
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 (mean changes from baseline).
Measured: Days 0, 7 and 14
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.
Measured: Day 14
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.
Measured: Day 7 and 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 20231 Apr 2024

First posted12 Apr 2024
Study start25 Apr 2023
Primary completion1 Apr 2024
Study completion1 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Wound HealStudies of the same condition, open and under way.
More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06363955
Sponsor's protocol ID: UNIMOUTH
Other IDs: 750/13.02.2023
Status last verified: Jul 2024
First submitted: 5 Apr 2024
Last updated: 3 Jul 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data that supports the findings of this study will be available from the corresponding author upon reasonable request.

Publications

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.
PubMed 3983264
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.
PubMed 7500245
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.
PubMed 11250628
Landry RGTR, Howley T. Effectiveness of benzydamine HCl in the treatment of periodontal post-surgical patients. Res Clinic Forums 1988;10:105-118.
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.
PubMed 14121956
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.
PubMed 14158464
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.
PubMed 22959491
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.
PubMed 22244162
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.
PubMed 30405935
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.
PubMed 379049
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.
PubMed 33178277

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Placebo-Controlled Clinical Trial Assessing the Efficacy of a Carbamide Peroxide 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
ClinicalTrials.gov ID: NCT06363955
Acronym / sponsor ID: UNIMOUTH
Conditions: Wound Heal, Oral Dryness, Postoperative Pain, Sjogren's Syndrome, Biopsy Wound, Mouth; Wound
Keywords: Oral Wound Healing, Oral Biopsy, Postoperative Symptoms, Oral Hygiene, Mouthwash, Hydrogen Carbamide, Hydrogen Peroxide, Sjogren's Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: National and Kapodistrian University of AthensUniversity, hospital or other
Collaborators: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
Study start: 25 Apr 2023 (actual)
Primary completion: 1 Apr 2024 (actual)
Study completion: 1 Apr 2024 (actual)
First posted: 12 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The evaluation includes:

oral wound healing (primary intention) assessed by scores (primary outcome) and secondarily:
oral wound healing via measuring the incision/wound length
postoperative symptoms (such as pain, eating and speech difficulties)
quality of life assessed by a questionnaire
improvement of dry mouth through subjective and objective measurements
oral hygiene via plaque and gingival indices.

All data are anonymized and the outcome assessors are masked.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Carbamide Peroxide Mouthwash	Experimental	Device: Carbamide Peroxide MouthwashA mouthwash containing carbamide proxide/hydrogen peroxide as active ingredient
Placebo	Placebo comparator	Device: Placebo mouthwashA mouthwash that looks, smells and tastes like the experinmental mouthwash without active ingredients

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Carbamide Peroxide MouthwashAlso: Hydrogen Peroxide MouthwashThe 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.	Device	Carbamide Peroxide Mouthwash
Placebo mouthwashPlacebo 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.	Device	Placebo

Primary outcome

Assessment of wound healing based on the modified Landry Healing Index on day 14
Time frame: 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.
Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14
Time frame: 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.
Assessment of wound healing based on the modified Landry Healing Index on day 7
Time frame: 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.
Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 7
Time frame: 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.

11 secondary outcomes

Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home)
Time frame: Days 0, 1, 2, 3, 4, 5 and 6
Postoperative symptoms (pain, eating and speech difficulty) on day 7
Time frame: Day 7
Postoperative symptoms (pain, eating and speech difficulty) on day 14
Time frame: Day 14
Wound healing based on the incision/wound length
Time frame: Days 0, 7 and 14
Subjective oral dryness symptoms (8-item VAS questionnaire)
Time frame: Days 0, 7 and 14
Observed (objective) signs of oral dryness
Time frame: Days 0, 7 and 14
Change in Unstimulated Saliva Flow Rate
Time frame: Days 0 and 14
Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index
Time frame: Days 0, 7 and 14
Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index
Time frame: Days 0, 7 and 14
Oral Health Related Quality of Life
Time frame: Day 14
Assessment of swelling in the biopsy area
Time frame: Day 7 and 14

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Background: PubMed 3983264Fox 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.
Background: PubMed 7500245Marshall 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.
Background: PubMed 11250628Pai 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.
BackgroundLandry RGTR, Howley T. Effectiveness of benzydamine HCl in the treatment of periodontal post-surgical patients. Res Clinic Forums 1988;10:105-118.
Background: PubMed 14121956LOE 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.
Background: PubMed 14158464SILNESS 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.
Background: PubMed 22959491Osailan 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.
Background: PubMed 22244162Papagiannopoulou 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.
Background: PubMed 30405935Marini 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.
Background: PubMed 379049Wennstrom 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.
Background: PubMed 33178277Muniz 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.
Individual participant dataSharing planned: Yes. The data that supports the findings of this study will be available from the corresponding author upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nikolaos Nikitakis, DDS, MD, PhD study chair

School of Dentistry, National and Kapodistrian University of Athens

Nikolaos Apostolidis, DDS principal investigator

School of Dentistry, National and Kapodistrian University of Athens

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Carbamide Peroxide Mouthwash in people with Wound Heal and Oral Dryness, run by National and Kapodistrian University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of wound healing based on the modified Landry Healing Index on day 14 (time frame: Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06363955, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.