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NCT Number: NCT06633627

Neurological Responses in Patients with Dentine Hypersensitivity

Dentine hypersensitivity (also known as sensitive teeth) is a common dental condition in which the dentine, a layer of sensitive hard tissue under the enamel of the teeth, becomes exposed making the teeth sensitive to stimuli, such as hot and cold. It poses a significant challenge for clinicians and affects patients' quality of life.

The overall aim of the study is to understand if a way of measuring brain activity (electroencephalography [EEG]) shows a response to tooth stimulation, and see how these responses may be different in patients with dentine sensitivity.

EEG records brain signals and can provide information about how the brain processes painful stimuli. EEG recording is a non-evasive and painless procedure. It involves using a cap with small sensors called electrodes to pick up brain signals. During the EEG assessment appointment, brain signals will be recorded throughout the duration when cold temperatures and short bursts of air are applied to the tooth. Brain signals recorded during tooth stimulation from participants with and without dentine sensitivity will then be compared to explore if there are any differences.

The investigators hope that EEG responses could be helpful to objectively assess dentine sensitivity, further the understanding of brain processing of dental pain, and allow the comparison of the effectiveness of different treatment options in the future.

This information may help to improve treatments and the quality of life for patients with dentine sensitivity and potentially other types of dental pain.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location status: Recruiting

Location contact

Alessia Dunn

CONTACT

[email protected]

01142712550

Fiona Boissonade, BDS, PhD

CONTACT

Mahnaz Arvaneh, PhD

CONTACT

Mark Barber, BDS, MFDS RCS, PgCertEd, MPhil

CONTACT

Natalie Wong, PhD

CONTACT

About this study

Dentine hypersensitivity (DH) is a common dental condition that has been defined as a 'short, sharp pain arising from exposed dentine in response to stimuli typically thermal, evaporative, tactile, osmotic or chemical and which cannot be ascribed to any other form of dental defect or pathology'. Many DH interventions have been investigated over the last 60 years, but a lack of standardisation of pain measurement and objectivity of measures are major limitations for assessing the efficacy of products (or understanding why products fail). A potential solution to this problem is greater understanding of the pain propagation mechanism from controlled stimulus to objective, measurable markers of pain severity.

EEG (electroencephalography) is a non-invasive technique that measures the electrical activity of the brain using the electrodes placed on the scalp. EEG provides information about the brain's electrical activity over time, helping diagnose and understand certain neurological conditions. The investigators have carried out a number of studies using human dental pulp and other human tissue to further understand the mechanisms of pain including pulpal pain.

Evoked potentials are EEG responses to specific stimuli, such as light, sound or heat. Pain-evoked potentials from tooth pulp are evoked potentials specifically related to pain originating from the pulp of a tooth. This type of measurement records the brain's electrical response to a stimulus applied to a tooth, such as thermal stimuli. The resulting EEG recording can provide information about how the central nervous system processes painful stimuli, including the speed and magnitude of the response. It was hypothesised that EEG pain-evoked potentials, if generated and measured in a controlled and repeatable way, can potentially be used (in conjunction with other diagnostic methods) to objectively evaluate the severity of dentine sensitivity and compare the efficacy of different treatment options.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 18 years and older;
  • Understands and is willing, able and likely to comply with all study procedures and restrictions;
  • Accepts the form of the study and signs a declaration of informed consent;
  • In good health (in the opinion of the clinical dental professional);
  • A minimum of 10 teeth not including teeth with crowns or bridges from upper right 4 to upper left 4 and lower right 4 to lower left 4;

For patients with dentine sensitivity only (experimental group): self-reported sensitivity in at least 1 tooth; confirmed by response to air puff.

Exclusion criteria

  • Adults currently using maxillary or mandibular orthodontic appliances;
  • Obvious signs of untreated caries, which in the opinion of the clinical dental professional, will affect the scientific validity of the study;
  • Periodontal pocket depth ≥4mm in the anterior upper or lower sextants;
  • Evidence of periodontitis.
  • Have a history of seizures;
  • Taking medications that affect brain responses;
  • Experience damaged skin on the scalp due to cuts, psoriasis, eczema, or other conditions;
  • Any participant who in the investigator's judgment will not comply with the study protocol;
  • Any participant who has difficulties in adequate understanding of English.

Treatment and study plan

Recording of brain activity using electroencephalography (EEG)

Other

Electroencephalography (EEG) responses to sensitivity stimuli applied to the teeth in patients with and without dentine hypersensitivity will be compared

Primary outcomes

  1. Electroencephalography (EEG) responses to tooth stimulation

    Time frame: 1 hour

    EEG responses to tooth stimulation will be measured, and EEG responses will be compared between participants with and without sensitive teeth

Secondary outcomes

  1. Correlation between Dentine hypersensitivity experience questionnaire (DHEQ) score and EEG responses

    Time frame: 30 minutes

    Participants will be asked to complete the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The DHEQ has 48 questions of which 34 comprise an impact scale. The DHEQ score is calculated as the sum of the scores from the questions, with a possible range of 34-238. A higher DHEQ score indicates that dentine hypersensitivity has a greater impact on the participant's quality of life.

    DHEQ score will be correlated with EEG responses recorded during tooth stimulation.

Study contacts

Contact information is provided by the study sponsor or research team.

Fiona Boissonade, BDS, PhD

CONTACT

[email protected]

+441142159314

Natalie Wong, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • HALEON
  • University of Sheffield

Registry information

Official study title

Identification and Quantification of Neurological Responses in Patients with Dentine Hypersensitivity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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