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Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth

2026년 5월 13일 업데이트: Edith Lara-Carrillo, Universidad Autonoma del Estado de Mexico

Hyposalivation is a condition that has increased in frequency, primarily due to the degeneration of salivary glands caused by aging, polypharmacy, chronic or autoimmune diseases, or radiation treatments. Most of these factors are associated with the elderly, a growing demographic due to the aging population. Therefore, addressing this condition has become crucial in our population, as has understanding how it affects their quality of life. Given that saliva plays a vital role in maintaining the oral mucosa, tooth structure, initiating digestion, and even speech, a long-term treatment to stimulate salivary production would be extremely helpful in resolving these problems. Currently, only palliative measures that temporarily cover or lubricate the oral cavity and its structures are available.

Among the most innovative treatments is neuroelectrical stimulation (TENS) as an adjunct in the therapy of dry mouth, which has shown improvement; however, this improvement has not been quantified through objective measurements that would allow for determining the quantity and quality of saliva, nor in the long term. Likewise, the patient's quality of life affected by this condition has not been assessed.

Therefore, the objective of this project is to evaluate the effect on salivary quality and quantity after the application of neuroelectrical stimulation as a treatment for patients with dry mouth, as well as their quality of life.

연구 개요

상세 설명

Participants: Patients attending the Orocentro Clinic of the Faculty of Dentistry at the Autonomous University of the State of Mexico with dry mouth symptoms who, upon diagnosis, present with hyposalivation, and who provide their consent and assent to participate in the study.

Sampling: Non-probabilistic, quota and convenience sampling.

Procedure A clinical examination will be performed to identify patients with dry mouth for confirmatory diagnosis and collection of clinical data. If necessary, a biopsy will be taken to identify Sjögren's disease. After obtaining informed consent and assent, baseline salivary samples will be taken for comparison after neuroelectrostimulation treatment. The Xerostomia Quality of Life Questionnaire will also be administered to assess any changes in quality of life following treatment.

To evaluate oral moisture, the time it takes for saliva droplets to form on the inner surface of the buccal mucosa of the lower lip will be measured; this should be less than 60 seconds.

Subsequently, the stimulated saliva will be collected by instructing the patient to chew paraffin gum for 5 minutes and then pour all the saliva produced into a calibrated cup. Saliva samples will be collected between 10 and 11 a.m. on study days to standardize the effect of circadian rhythms on salivary parameter assessment. All participants will be instructed to refrain from chewing gum or candy, eating, drinking any liquids or alcohol, smoking, or brushing their teeth for approximately two hours prior to sample collection.

Salivary pH and buffering capacity will be evaluated using reagent strips (Saliva-Check Buffer (GC, Alsip, IL, USA)) by immersing them in the stimulated saliva sample. The value will be assigned by colorimetric comparison with the manufacturer's chart. Saliva viscosity will be visually determined. Photographic records of the measurements will be taken to clarify any doubts in their interpretation. After determining the salivary values, and if the participant requests and accepts it, neuro-electrostimulation will be applied. This application will be performed using self-adhesive electrodes (Theratrode or Physiotrode). Before placing the electrodes, the skin area corresponding to the parotid and submandibular glands will be cleaned. The electrodes will be placed bilaterally in this area, and the BTL device will be programmed to TENS current mode with parameters of 4 Hz and a wavelength of 250 µs. The intensity will be adjusted until a visible contraction of the facial muscles is achieved and the patient tolerates it.

The Sialometry will be obtained before and after therapy. TENS will be applied twice a week for three weeks. If no changes are seen, the therapy will be changed to magnetic fields.

Participants will be followed up at 6 months, during which maintenance therapy will be carried out, and again 1 year after the application of the first therapy.

Quality of life and identification of oral lesions will be assessed at two time points (before and at the end of the study). This therapy may vary depending on the severity of the case (hyposalivation/Sjögren's syndrome).

Many of these patients require tooth extractions due to dental demineralization and loss of healthy supporting tissues. In these cases, the demineralization of the extracted tooth caused by the lack of mineral content provided by saliva will be evaluated through Vickers microhardness and Diagnodent measurements.

Statistical analysis The results will be subjected to the SPSS statistical package, version 26, obtaining descriptive statistics and checking the normality of the corresponding samples, in order to apply the Student's T test for paired samples, ANOVA of repeated measures and Pearson correlation to relate sociodemographic data, with a p-value≤0.05 to find statistically significant differences.

연구 유형

중재적

등록 (추정된)

35

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Edith Lara-Carrillo, PhD
  • 전화번호: 132 +527222126464
  • 이메일: elarac@uaemex.mx

연구 연락처 백업

  • 이름: Víctor Hugo Toral-Rizo, PhD
  • 전화번호: +525540759303
  • 이메일: vhtoralr@uaemex.mx

연구 장소

    • State of Mexico
      • Toluca, State of Mexico, 멕시코, 50130
        • 모병
        • Clinic of Oral Medicine and Pathology "Orocentro", School of Dentistry, Autonomous University of the State of Mexico
        • 연락하다:
          • Victor Hugo Toral-Rizo, PhD
          • 전화번호: +527269721268
          • 이메일: vhtoralr@uamex.mx

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  • Patients diagnosed with dry mouth symptoms.
  • Patients who wish to participate in the study.
  • Patients who allow saliva samples to be collected before, during, and after treatment.
  • Patients who allow the application of transcutaneous electrical nerve stimulation (TENS).
  • Patients who do not have any active oral infections.
  • Patients who attend all sialometry assessments and physiotherapy sessions and complete both quality of life questionnaires (initial and final).

Exclusion Criteria:

  • Patients with any other mucosal alteration.
  • Patients who do not wish to participate in the study.
  • Patients who do not allow the collection of saliva samples.
  • Patients who do not allow the application of transcutaneous electrical nerve stimulation (TENS).
  • Patients with any infectious process in the oral cavity.
  • Because the study requires the use of low-frequency pulse currents, participants with pacemakers, defibrillators, hearing aids, or cochlear implants will also be excluded from the study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: neuroelectrostimulation
Neuro-electrostimulation will be applied, this application will be carried out with self-adhesive electrodes (Theratrode or Physiotrode) for 30 minutes with the parameters of 4Hz and wavelength of 250µs and the intensity will be adjusted until there is a visible contraction of the facial muscles and the patient's tolerance.
Previous studies have evaluated the impact of TENS on improving salivary hypofunction, mentioning that placing the device on the parotid gland stimulates the postganglionic efferent fibers of the auriculotemporal nerve, improving the secretomotor impulse of the parotid gland.
실험적: magnetic fields
A second therapy involves the application of magnetic fields if neurostimulation does not increase saliva production. This is applied for 30 minutes.
Previous studies have evaluated the impact of TENS on improving salivary hypofunction, mentioning that placing the device on the parotid gland stimulates the postganglionic efferent fibers of the auriculotemporal nerve, improving the secretomotor impulse of the parotid gland.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Salivary flow rate (mL/min)
기간: one year
Change in salivary flow rate (mL/min), from baseline to after the application of 6 neuro-electro-stimulation therapies or magnetic fields according to the branch of the study. Evaluation after 6 months and up to 1 year.
one year
Salivary pH
기간: one year
Salivary pH will be measured to assess salivary acidity from baseline to after the application of 6 neuro-electro-stimulation therapies or magnetic fields according to the branch of the study. Evaluation after 6 months and up to 1 year.
one year
Buffer capacity of saliva
기간: one year
Change in buffer capacity saliva from baseline to after the application of 6 neuro-electro-stimulation therapies or magnetic fields according to the branch of the study. Evaluation after 6 months and up to 1 year.
one year

2차 결과 측정

결과 측정
측정값 설명
기간
Change in health-related quality of life
기간: One month
Change in health-related quality of life measured by the Xerostomia Quality of Life Questionnaire (XeQoLS) from baseline to 4 weeks after physiotherapy treatment.
One month

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Edith Lara-Carrillo, PhD, Professor, School of Dentistry, Autonomous University of the State of Mexico

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 2월 1일

기본 완료 (추정된)

2026년 7월 31일

연구 완료 (추정된)

2027년 7월 31일

연구 등록 날짜

최초 제출

2026년 2월 2일

QC 기준을 충족하는 최초 제출

2026년 5월 13일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 13일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Anonymized individual data supporting the study results will be shared with qualified researchers upon reasonable request, following publication of the results, through an institutional repository and under a data use agreement.

IPD 공유 기간

The study results will be shared upon reasonable request, following publication of the results

IPD 공유 액세스 기준

Access to anonymized individual data will be available to qualified researchers who submit a methodologically sound scientific proposal, approved by the research team. Access will be subject to the signing of a data usage agreement.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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