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The Effect of Ozone on Salivary Flow in Patients With Xerostomia and Hyposalivation After Radiotherapy (OZONEXEROSTOMI) (ozonexerostomi)

2026년 5월 4일 업데이트: Sergio Bruzadelli Macedo, University of Brasilia

The Effect of Ozone Therapy on Salivary Flow and Quality of Life in Patients With Xerostomia and Hyposalivation After Head and Neck Radiotherapy

Patients who underwent head and neck radiotherapy and developed xerostomia and/or hyposalivation will be selected. The patients will be randomly assigned into two groups, defined as control and treatment.

All patients will complete the xerostomia-related quality of life questionnaires, XeQoLS (Xerostomia Quality of Life Scale) and OHIP (Oral Health Impact Profile). This qualitative assessment will be repeated 1 week after the 6th application and 1 week after the 12th application (T0, T6, and T12).

The quantitative assessment will be carried out through the collection of unstimulated and stimulated saliva at the same time points (T0, T6, and T12).

Patients will undergo 12 sessions of ozone therapy, once a week, in gaseous form, at a concentration of 10 µg/mL (micrograms per milliliter), applied directly into the major salivary glands.

The gas will be administered as follows:

  • Parotid glands: two distinct points per gland, 1 mL at each point.
  • Submandibular glands: one point per gland, 1 mL per point at 10 µg/mL.
  • Sublingual glands: one point per gland, 1 mL per point at 10 µg/mL. The ozone generator equipment will be supplied with medical oxygen (99.5% purity), Dental model, Philozon company.

Disposable syringes will be Terumo, 10 mL, and the needle will be BD, 30/13 mm.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

  • 이름: Sergio B Macedo, PhD
  • 전화번호: +5561981276050
  • 이메일: bruzadelli@unb.br

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Patients who have undergone head and neck radiotherapy
  • Patient who have developed xerostomia
  • Patient who have developed hyposalivation

Exclusion Criteria:

  • Patients with active malignant disease
  • Patients who do not agree to sign the informed consent form

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ozone therapy

Ozone gas will be applied as follows:

  • Parotid glands: two distinct points per gland, 1 mL at each point (10 µg/mL). The anatomical reference will be the parotid region, located anterior and inferior to the external ear.
  • Submandibular glands: one point per gland, 1 mL at 10 µg/mL. The anatomical reference will be the mandibular base, anterior to the angle, considering its inner aspect.
  • Sublingual glands: one point per gland, 1 mL at 10 µg/mL. The anatomical reference will be the region of the lower lateral incisor, lingual aspect, punctured through the floor of the mouth mucosa, adjacent to the lingual surface of the mandibular bone.

The ozone generator (Dental model, Philozon, Brazil) will be supplied with medical oxygen (99.5% purity).
다른: Ozone therapy

Experimental: Ozone Therapy

Ozone gas will be applied as follows:

  • Parotid glands: two distinct points per gland, 1 mL at each point (10 µg/mL). The anatomical reference will be the parotid region, located anterior and inferior to the external ear.
  • Submandibular glands: one point per gland, 1 mL at 10 µg/mL. The anatomical reference will be the mandibular base, anterior to the angle, considering its inner aspect.
  • Sublingual glands: one point per gland, 1 mL at 10 µg/mL. The anatomical reference will be the region of the lower lateral incisor, lingual aspect, punctured through the floor of the mouth mucosa, adjacent to the lingual surface of the mandibular bone.

The ozone generator (Dental model, Philozon, Brazil) will be supplied with medical oxygen (99.5% purity).
간섭 없음: no treatment
Patients in the control group will not receive any treatment but will complete the xerostomia-related quality of life questionnaires and undergo salivary flow assessment at T0, T6, and T12

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Salivary flow
기간: Time 0 weeks

The assessment of unstimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016.

The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes. The unit of measurement will be in microliters.
Time 0 weeks
Salivary flow
기간: time 6 weeks

The assessment of unstimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016.

The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes. The unit of measurement will be in microliters.
time 6 weeks
Salivary Flow
기간: 12 week
The assessment of unstimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016. The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes. The unit of measurement will be in microliters.
12 week
Salivary flow
기간: Time 0 weeks
The assessment of stimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016. The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes. Stimulated saliva will be collected using the same procedure, preceded by chewing a piece of silicone for 1 minute. The unit of measurement will be in microliters.
Time 0 weeks
Salivary flow
기간: Time 6 weeks
The assessment of stimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016. The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes. Stimulated saliva will be collected using the same procedure, preceded by chewing a piece of silicone for 1 minute. The unit of measurement will be in microliters.
Time 6 weeks
Salivary flow
기간: Time 12 weeks
The assessment of stimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016. The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes. Stimulated saliva will be collected using the same procedure, preceded by chewing a piece of silicone for 1 minute. The unit of measurement will be in microliters.
Time 12 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Xerostomia-Related Quality of Life Scale (XeQoLS)
기간: time 0 weeks
The Xerostomia-Related Quality of Life Scale (XeQoLS) consists of 15 items, each scored from 0 to 4 according to the severity of xerostomia impact. The final score is calculated as the mean of all items, resulting in a total score ranging from 0 to 4, where 0 indicates no impact and 4 indicates maximum impact. Higher scores indicate worse xerostomia-related quality of life.
time 0 weeks
Xerostomia-Related Quality of Life Scale (XeQoLS)
기간: time 6 weeks
The Xerostomia-Related Quality of Life Scale (XeQoLS) consists of 15 items, each scored from 0 to 4 according to the severity of xerostomia impact. The final score is calculated as the mean of all items, resulting in a total score ranging from 0 to 4, where 0 indicates no impact and 4 indicates maximum impact. Higher scores indicate worse xerostomia-related quality of life.
time 6 weeks
Xerostomia-Related Quality of Life Scale (XeQoLS)
기간: time 12 weeks
The Xerostomia-Related Quality of Life Scale (XeQoLS) consists of 15 items, each scored from 0 to 4 according to the severity of xerostomia impact. The final score is calculated as the mean of all items, resulting in a total score ranging from 0 to 4, where 0 indicates no impact and 4 indicates maximum impact. Higher scores indicate worse xerostomia-related quality of life.
time 12 weeks
Oral Health Impact Profile-14 (OHIP-14)
기간: time 0 weeks

The Oral Health Impact Profile-14 (OHIP-14) is a validated questionnaire consisting of 14 items assessing the impact of oral health on quality of life. Each item is scored from 0 to 4 based on frequency of impact (0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often).

The total score is calculated as the sum of all items, ranging from 0 to 56, with higher scores indicating worse oral health-related quality of life.
time 0 weeks
Oral Health Impact Profile-14 (OHIP-14)
기간: time 6 weeks

The Oral Health Impact Profile-14 (OHIP-14) is a validated questionnaire consisting of 14 items assessing the impact of oral health on quality of life. Each item is scored from 0 to 4 based on frequency of impact (0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often).

The total score is calculated as the sum of all items, ranging from 0 to 56, with higher scores indicating worse oral health-related quality of life.
time 6 weeks
Oral Health Impact Profile-14 (OHIP-14)
기간: time 12 weeks

The Oral Health Impact Profile-14 (OHIP-14) is a validated questionnaire consisting of 14 items assessing the impact of oral health on quality of life. Each item is scored from 0 to 4 based on frequency of impact (0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often).

The total score is calculated as the sum of all items, ranging from 0 to 56, with higher scores indicating worse oral health-related quality of life.
time 12 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Brasilia

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 (추정된)

2026년 7월 15일

기본 완료 (추정된)

2027년 7월 15일

연구 완료 (추정된)

2028년 1월 15일

연구 등록 날짜

최초 제출

2026년 4월 27일

QC 기준을 충족하는 최초 제출

2026년 5월 4일

처음 게시됨 (실제)

2026년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 4일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 66681722.6.0000.0030

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Individual data will be made available as supplementary material in the final publication.

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

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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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