Oxidative Stress and Antioxidant Responses During Rapid Maxillary Expansion: A Controlled Clinical Study
Rapid maxillary expansion is an orthopedic treatment used to correct transverse maxillary deficiency in growing patients. Mechanical forces generated during expansion may induce local biological responses, including changes in oxidative stress and antioxidant defense mechanisms.
This prospective, non-randomized, controlled pilot study evaluated changes in oxidative and antioxidant biomarkers in gingival crevicular fluid during rapid maxillary expansion and the early retention period. Twenty-eight participants aged 10 to 13 years were included: 14 patients undergoing rapid maxillary expansion and 14 age- and sex-matched untreated controls.
Gingival crevicular fluid samples and periodontal measurements were collected at six corresponding time points. Malondialdehyde, reduced glutathione, glutathione peroxidase, and vitamin C were measured. The study aimed to characterize local biochemical changes associated with the treatment period and to compare their longitudinal patterns with those observed in untreated controls.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Rapid maxillary expansion is widely used to correct transverse maxillary deficiency in growing patients. Although its skeletal and dentoalveolar effects are well established, the local biochemical responses associated with active expansion and early retention remain incompletely characterized. Mechanical loading may increase the production of reactive oxygen species and alter antioxidant defense mechanisms within periodontal tissues.
The purpose of this study was to evaluate longitudinal changes in oxidative stress and antioxidant biomarkers measured in gingival crevicular fluid during rapid maxillary expansion and to compare these changes with those observed in an untreated control group.
Twenty-eight consecutively recruited orthodontic patients aged 10 to 13 years were included. Fourteen patients with a clinical indication for rapid maxillary expansion formed the intervention group. Fourteen untreated participants, matched by age and sex, formed the control group. Treatment allocation was not randomized because the decision to perform rapid maxillary expansion was based on clinical need.
Participants in the intervention group were treated with a modified Hyrax rapid maxillary expander. The appliance was initially maintained without activation and was subsequently activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the planned expansion was achieved. After active expansion, the screw was stabilized with composite resin and the appliance was maintained as a retention device.
Clinical periodontal assessments and gingival crevicular fluid sampling were performed at six time points: baseline; 24 hours after appliance placement; 7 days after appliance placement during the passive phase; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention. Control participants underwent the same assessment schedule without orthodontic intervention.
Gingival crevicular fluid was analyzed for malondialdehyde, reduced glutathione, glutathione peroxidase activity, and vitamin C. Biomarker values were normalized to total protein concentration. Periodontal measurements included gingival index, plaque index, probing depth, and keratinized tissue percentage.
The study was exploratory and no formal prospective sample size calculation was performed. The findings were intended to characterize local biochemical changes in gingival crevicular fluid and were not designed to provide direct evidence of skeletal or midpalatal suture remodeling.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Izmir, 터키 (Türkiye), 35140
- Izmir Democracy University
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 10 and 13 years.
- Good general health.
- Fully erupted maxillary premolars.
- Healthy periodontal status, with probing depth of 3 mm or less.
- For the intervention group, a clinical indication for rapid maxillary expansion.
- For the control group, no orthodontic treatment planned during the observation period.
- Ability to comply with the clinical examination and gingival crevicular fluid sampling schedule.
- Written informed consent from the participant's parent or legal guardian and assent from the participant, where applicable.
Exclusion Criteria:
- Systemic disease.
- Current medication use that could influence periodontal, inflammatory, or oxidative status.
- Active periodontal disease.
- Probing depth greater than 3 mm.
- Inability to comply with the oral hygiene protocol or study visits.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
간섭 없음: No intervention
Age- and sex-matched participants who did not receive orthodontic treatment during the observation period.
Participants underwent the same periodontal examinations and gingival crevicular fluid sampling schedule as the intervention group.
|
|
|
실험적: Expansion
A tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw.
The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved.
The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period.
|
A tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw.
The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved.
The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in gingival crevicular fluid malondialdehyde level
기간: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
|
Malondialdehyde in gingival crevicular fluid was assessed using a thiobarbituric acid reactive substances method and normalized to total protein concentration.
Higher values indicate greater local lipid peroxidation.
|
Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in gingival crevicular fluid reduced glutathione level
기간: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
|
Reduced glutathione was measured spectrophotometrically and normalized to total protein concentration
|
Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
|
|
Change in gingival crevicular fluid glutathione peroxidase activity
기간: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
|
Glutathione peroxidase activity was measured spectrophotometrically and normalized to total protein concentration
|
Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
|
|
Change in gingival crevicular fluid vitamin C level
기간: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
|
Vitamin C was measured using a colorimetric spectrophotometric method and normalized to total protein concentration.
|
Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
|
공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- Oxidative Stress Expansion
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .