Clinical and Radiographic Outcomes After Flapless Approach of Intrabony Defects With the Application of Enamel Matrix Derivative Versus Hyaluronic Acid: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Radiographic bone fill
研究概览
简要总结
The goal of this clinical trial is to radiographically assess the effectiveness of minimally invasive non-surgical technique (MINST) combined with local administration of sodium hypochlorite gel (Perisolv®) and 1.6% cross-linked hyaluronic acid (HA, Hyadent BG®) compared to a neutral formulation of EDTA (Prefgel®) and enamel matrix derivative (EMD, Emdogain® FL) in periodontal regeneration. The main questions it aims to answer are:
- ¿Does the combination of MINST with the local administration of sodium hypochlorite gel and 1.6% cross-linked hyaluronic acid show a potential for periodontal regeneration similar to evaluating clinical and radiographic variables compared to a neutral formulation of EDTA and enamel matrix derivative?
- ¿What is the patient perception and satisfaction with the received treatment?
Researchers will compare A (MINST with Perisolv® + Hyadent BG®), B (MINST with PrefGel® + Emdogain® FL) and C(MINST without any bioactive product).
The sample will be distributed according to the following treatments:
- Experimental group: Scaling and root planing (SRP), MINST with Perisolv® + Hyadent BG®.
- Active comparator group: SRP, MINST with PrefGel® + Emdogain® FL.
- Control group: SRP, MINST without any bioactive product.
Patients will be screened by a first visit in which they will be assigned their periodontal status. If they meet the eligibility criteria, they will be treated according to the EFP clinical guideline for periodontitis treatment: step I and step II.If the periodontal defect persists at the 12-week re-evaluation, patients will be randomised to treatment A, B or C.
After the intervention, all participants will be checked weekly for the first 6 weeks to remove accumulated plaque, and every 3 months for 1 year. Periodontal parameters will be re-evaluated 6 and 12 months after periodontal regenerative intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontitis stage III or IV, grade A or B (Tonetti et al., 2017): attachment loss ≥ 5mm, radiographic bone loss extending to to the middle third and beyond, tooth loss ≥4 due to periodontitis, probing depth (PD) ≥ 6mm.
- •Older adults ≥ 18 years. The number per sex shall be balanced.
- •Plaque index (PI) < 1 following initial periodontal therapy and hygiene instructions.
- •Bleeding on probing (BoP) ≤ 10%.
- •Only patients with optimal compliance, assessed during etiological therapy, will be selected.
- •At least a 2-3 wall interproximal bone defect with a radiographically moderate or deep intrabony defect (≥3mm), PD≥ 6mm using a Williams probe on uniradicular teeth or mandibular molars without furcation involvement after non-surgical periodontal treatment.
- •Vital teeth or teeth with well-performed root canal treatment.
- •Absence of caries, prosthetic restoration or periapical infection in the tooth to be regenerated.
- •Absence of systemic pathology.
- •Negative history of pregnancy.
- •Signed informed consent.
- •The participant is willing and able to comply with the necessary visits for the treatments and evaluations scheduled during the clinical study.
排除标准
- •The participant is pregnant, breastfeeding or plans to become pregnant in the next 6 months.
- •Smoking ≥10 cigarettes/day.
- •Daily alcohol intake > 4U.
- •Chronic illness or reduced mental capacity that may influence compliance with the protocol.
- •Medications or drugs that alter the patient's healing or with concomitant oral manifestations that, in the opinion of the investigator, could interfere with the assessment of safety or efficacy.
- •Systemic diseases that may influence treatment such as diabetes mellitus or rheumatoid disease.
- •Allergies to drug compounds.
- •Antibiotic intake 3 months prior to the start of the study or systemic condition requiring antibiotic coverage at the time of periodontal treatment.
- •Periodontal treatment 6 months prior to the start of the study.
研究组 & 干预措施
(MINST + EDTA) + EMD
干预措施: Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application (Procedure)
(MINST + NaOCl) + HA
干预措施: Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application (Procedure)
MINST
干预措施: Flapless instrumentation of the defect and product application simulation (Procedure)
结局指标
主要结局
Radiographic bone fill
时间窗: Baseline, 6 and 12 months.
Depth of the intraosseous defect (B - D); and following the healing period (X - C). Bone fill (BF) will be calculated by subtracting the (X - C) measurement recorded at the 6-month and 12-month postoperative review from the depth recorded before the regenerative intervention (B - D).
次要结局
- Gingival recession(Baseline, 6 and 12 months.)
- Clinical attachment level (CAL) gain(Baseline, 6 and 12 months.)
- Probing pocket depth (PD)(Baseline,6 and 12 months.)
- Bleeding on probing(Baseline, 6 and 12 months.)
- Plaque index(Baseline, 6 and 12 months.)
- Chair time(During procedure)
- Patient satisfaction and perception(1 week after baseline (regenerative intervention))
- Patient satisfaction and perception(6 months after baseline (regenerative intervention))
- Patient satisfaction and perception(12 months after baseline (regenerative intervention))
研究者
Andres Lopez Roldan
Assistant Professor with PhD
University of Valencia