Photodynamic Therapy as an Adjunct in Periodontal Treatment (PDT-PERIO)
Clinical Evaluation of Photodynamic Therapy as an Adjunct to Scaling and Root Planing in the Treatment of Periodontal Disease: A Split-Mouth Randomized Controlled Clinical Trial
연구 개요
상태
상세 설명
Periodontitis is a chronic inflammatory disease characterized by the destruction of the supporting tissues of the teeth and is one of the leading causes of tooth loss worldwide. Scaling and root planing (SRP) is considered the gold standard non-surgical treatment; however, complete elimination of periodontal pathogens may be difficult in deep periodontal pockets and anatomically complex sites.
Antimicrobial photodynamic therapy (aPDT) has emerged as a minimally invasive adjunctive treatment. This technique combines a photosensitizing agent, toluidine blue O, with low-level laser irradiation to produce reactive oxygen species capable of destroying periodontal pathogens while minimizing damage to host tissues.
This study will be conducted at the Dental Clinic of the Universidad Católica de Santiago de Guayaquil, Ecuador. Thirty adult patients diagnosed with periodontitis will be enrolled. A split-mouth randomized design will be used, with one hemiarch receiving SRP alone (control) and the contralateral hemiarch receiving SRP plus aPDT (test group).
Clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and gingival index (GI) will be recorded at baseline and at 30-day follow-up. The primary objective is to compare the clinical effectiveness of adjunctive aPDT versus conventional SRP alone in improving periodontal health outcomes.
The study has been approved by the Ethics Committee for Research in Human Subjects of the Universidad Católica de Santiago de Guayaquil (CEISH-UCSG) and will be conducted in accordance with ethical principles for human research.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: GABRIELA G ZAMBRANO MANZABA, DDS
- 전화번호: +19546298543
- 이메일: gabriela.zambrano06@cu.ucsg.edu.ec
연구 장소
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Guayas
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Guayaquil, Guayas, 에콰도르, 090101
- Dental School, Catholic University of Santiago de Guayaquil (UCSG)
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부수사관:
- HECTOR A LEMA GUTIERREZ, DDS
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연락하다:
- GABRIELA G ZAMBRANO MANZABA, DDS
- 전화번호: 9546298543
- 이메일: gabriela.manzaba30@gmail.com
-
연락하다:
- GABRIELA ZAMBRANO MANZABA, DDS
- 전화번호: 9546298543
- 이메일: gabriela.zambrano06@cu.ucsg.edu.ec
-
부수사관:
- PABLO M REYES CUENCA, DDS
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수석 연구원:
- GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 to 65 years.
- Diagnosis of Stage I, II, III, or IV periodontitis according to the 2018 World Workshop Classification.
- Presence of at least two hemiarches with periodontal pockets ≥5 mm suitable for a split-mouth design.
- Systemically healthy individuals.
- No periodontal treatment received within the previous 6 months.
- No use of antibiotics, anti-inflammatory drugs, or antiseptic mouth rinses within the previous 3 months.
- Ability and willingness to provide written informed consent and attend follow-up visits.
Exclusion Criteria:
- Uncontrolled systemic diseases that may affect healing or immune response.
- Use of antibiotics, corticosteroids, or immunosuppressive medications within the previous 3 months.
- Active smokers consuming more than 10 cigarettes per day.
- Pregnant or breastfeeding women.
- Presence of dental implants, defective restorations, or teeth with Grade III mobility in the selected study sites.
- Known allergy to toluidine blue O or any component of the photosensitizer.
- Individuals unable or unwilling to attend the 30-day follow-up visit.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Scaling and Root Planing (SRP)
Hemiarch treated with conventional non-surgical periodontal therapy consisting of scaling and root planing alone.
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Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
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실험적: Scaling and Root Planing Plus Antimicrobial Photodynamic Therapy (SRP + aPDT)
Hemiarch treated with conventional scaling and root planing combined with adjunctive antimicrobial photodynamic therapy using toluidine blue O and low-level laser irradiation.
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Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
Adjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Probing Pocket Depth (PPD)
기간: Baseline and 30 Days
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Mean change in probing pocket depth (PPD), measured in millimeters using a UNC-15 periodontal probe, comparing baseline and 30-day follow-up between treatment groups.
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Baseline and 30 Days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Clinical Attachment Level (CAL)
기간: Baseline and 30 Days
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Mean change in clinical attachment level (CAL), measured in millimeters from the cemento-enamel junction to the bottom of the periodontal pocket.
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Baseline and 30 Days
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Change in Bleeding on Probing (BOP)
기간: Baseline and 30 Days
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Percentage of sites presenting bleeding on probing after periodontal examination.
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Baseline and 30 Days
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Change in Plaque Index (PI)
기간: Baseline and 30 Days
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Percentage of dental surfaces with visible plaque assessed using the O'Leary plaque index.
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Baseline and 30 Days
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Change in Gingival Index (GI)
기간: Baseline and 30 Days
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Mean gingival index score assessed according to the Löe and Silness criteria.
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Baseline and 30 Days
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Wang P, Sun F, Ling X. Effectiveness of photodynamic therapy as an adjunctive treatment for periodontitis: A systematic review and meta-analysis. J Stomatol Oral Maxillofac Surg. 2025 Mar;126(2):102036. doi: 10.1016/j.jormas.2024.102036. Epub 2024 Sep 5.
- Nie M, Huang P, Peng P, Shen D, Zhao L, Jiang D, Shen Y, Wei L, Bible PW, Yang J, Wang J, Wu Y. Efficacy of photodynamic therapy as an adjunct to scaling and root planing on clinical parameters and microbial composition in subgingival plaque of periodontitis patients: A split-mouth randomized clinical trial. J Periodontol. 2024 Jun;95(6):535-549. doi: 10.1002/JPER.23-0195. Epub 2024 Mar 19.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CEISH-UCSG-045-2025. - CEISH-
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
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