Enhanced Early Soft-Tissue Healing With THERAVEX Technology
Comparison of New Bone Bioactive Liquid (BBL), 0.12% Chlorhexidine and Saline Solution Mouthwashes for Socket Healing One Week Postoperatively: A Randomized, Double Blinded Clinical Study
연구 개요
상태
정황
상세 설명
his randomized, double-blind clinical trial aims to evaluate the effect of different postoperative mouthwashes on early soft-tissue healing following tooth extraction. The study specifically investigates the efficacy of a mineral-based ionic oral rinse (THERAVEX Total Oral Care Plus) compared with 0.12% chlorhexidine and warm saline solution.
A total of 92 extraction sites from systemically healthy adult patients undergoing non-surgical tooth extraction were included. Participants were allocated to one of three intervention groups and followed for a period of 7 days. Intraoral digital scans were obtained immediately after extraction and at follow-up, and healing was assessed using three-dimensional surface analysis to quantify reduction in wound area over time.
The primary objective is to determine whether modulation of the local ionic microenvironment using THERAVEX Technology enhances early soft-tissue healing compared with conventional postoperative mouthwashes. Secondary analyses evaluate the influence of clinical variables such as sex, extraction site location, and dental arch on healing outcomes.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beirut, 레바논
- Saint Joseph University of Beirut
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Adults aged ≥18 years. Systemically healthy individuals. Patients requiring non-surgical tooth extraction of one to three teeth. Stable periodontal condition and adequate oral hygiene. Ability and willingness to comply with study procedures. Provision of written informed consent.
Exclusion Criteria:
Use of systemic antibiotics within the previous 3 months. Pregnancy or breastfeeding. Presence of infectious diseases or active oral infections. Immunosuppressive conditions or ongoing immunosuppressive therapy. History of bisphosphonate use. History of radiotherapy or chemotherapy. Heavy smoking habits. Uncontrolled systemic diseases. Any condition known to interfere with bone or soft-tissue healing.
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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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실험적: THERAVEX Total Oral Care Plus
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Participants used a mineral-based ionic oral rinse containing calcium, magnesium, and phosphate species.
The mouthwash was administered according to the manufacturer's instructions, starting 12 hours after tooth extraction, with rinsing performed twice daily for approximately one minute over a 7-day postoperative period.
Participants used a 0.12% chlorhexidine oral rinse, starting 12 hours after extraction, rinsing twice daily for approximately one minute for 7 days.
Participants used a warm saline solution prepared by dissolving one teaspoon of salt in approximately 240 mL of lukewarm water, rinsing twice daily for approximately one minute for 7 days.
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실험적: Chlorhexidine 0.12% Oral Rinse (Paroex)
Paroex
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Participants used a mineral-based ionic oral rinse containing calcium, magnesium, and phosphate species.
The mouthwash was administered according to the manufacturer's instructions, starting 12 hours after tooth extraction, with rinsing performed twice daily for approximately one minute over a 7-day postoperative period.
Participants used a 0.12% chlorhexidine oral rinse, starting 12 hours after extraction, rinsing twice daily for approximately one minute for 7 days.
Participants used a warm saline solution prepared by dissolving one teaspoon of salt in approximately 240 mL of lukewarm water, rinsing twice daily for approximately one minute for 7 days.
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위약 비교기: Warm Saline Rinse
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Participants used a mineral-based ionic oral rinse containing calcium, magnesium, and phosphate species.
The mouthwash was administered according to the manufacturer's instructions, starting 12 hours after tooth extraction, with rinsing performed twice daily for approximately one minute over a 7-day postoperative period.
Participants used a 0.12% chlorhexidine oral rinse, starting 12 hours after extraction, rinsing twice daily for approximately one minute for 7 days.
Participants used a warm saline solution prepared by dissolving one teaspoon of salt in approximately 240 mL of lukewarm water, rinsing twice daily for approximately one minute for 7 days.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Effect of Mouthwash Type on Healing
기간: 7 DAYS
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Comparison of healing percentage between intervention groups (THERAVEX, chlorhexidine, and saline) using linear mixed-effects models.
Early Healing Index (EHI)
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7 DAYS
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Early Soft-Tissue Healing Percentage
기간: 7 DAYS
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Percentage of soft-tissue healing at 7 days following tooth extraction, quantified by three-dimensional digital intraoral scanning and surface analysis.
Healing was defined as the reduction in wound surface area between baseline (immediately post-extraction) and day 7. Early Healing Index (EHI)
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7 DAYS
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Effect of Mouthwash Type on Healing
기간: 7 DAYS
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Comparison of healing percentage between intervention groups (THERAVEX, chlorhexidine, and saline) using linear mixed-effects models.Early Healing Index (EHI)
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7 DAYS
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Influence of Clinical Variables on Healing
기간: 7 DAYS
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Assessment of the effect of sex, extraction site location (anterior vs posterior), and dental arch (maxilla vs mandible) on healing outcomes.
Early Healing Index (EHI)
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7 DAYS
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Safety and Clinical Outcomes
기간: 7 DAYS
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Change in pain intensity measured using the Visual Analog Scale (VAS; 0-10, where 0 indicates no pain and 10 indicates worst possible pain) at Day 7 post-extraction Visual Analog Scale (VAS)
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7 DAYS
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- Tfemd-2025-31
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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