Comparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% (Hyadent BG®) and Enamel Matrix Derivative (Emdogain®) in Periodontal Regeneration: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Clinical measure: Clinical attachment loss (CAL). Changes will be assessed at 3 time points.
研究概览
简要总结
The aim of this study is to compare the effectiveness in periodontal regeneration of cross-linked hyaluronic acid at 1.8% (Hyadent BG®) with enamel matrix derivative (Emdogain®) in periodontal bone defects evaluating their clinical and radiographic variables.
详细描述
A high molecular weight polysaccharide, hyaluronic acid, also known as hyaluronan or hyaluronate, has recently been studied as a promising mediator for periodontal regeneration. It has a significant role in mineralized and non-mineralized periodontal tissues for the functioning of its extracellular matrices. It has a multifunctional role in periodontics including the stimulation of cell migration, proliferation and differentiation and the acceleration of wound healing by stimulating angiogenesis. It is used in surgical procedures due to its osteoinductive potential. HA is a key element in soft periodontal tissues, the gingiva and periodontal ligament, and in hard tissue, such as alveolar bone and cementum. It has many structural and physiological functions within these tissues.
This research proposes two experimental groups to whom one of them will be applied cross-linked hyaluronic acid at 1.8% and another group with enamel matrix derivative, and a control group.
The investigator's hypothesis is that the hyaluronic acid shows potential for periodontal regeneration when evaluating its clinical and radiographic variables and when compared with the use of Enamel matrix derivative.
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
- Double (Participant, Investigator)
盲法说明
Double-blinding: The researchers who performed the measurements will be different from those who performed the surgery; therefore, the examiner will be blinded during the entire duration of the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontitis stage II or III, grade A or B: based on the "Consensus report of workgroup of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions" Tonetti
- •Clinical attachment loss of 3-5mm, radiographic bone loss to the middle third, loss of teeth ≤4 due to periodontitis, probing depth ≥ 6 mm.
- •At least, 20 teeth in the mouth.
- •Plaque Index (PI) < 1, following initial nonsurgical periodontal therapy and hygiene instructions.
- •At least one interproximal 2, 3-wall bone defect with moderate to deep intrabony defects (≥3mm) on the radiographs, and clinical probing depths (PD) >5mm using William's graduated periodontal probe on premolars or molars following initial nonsurgical periodontal therapy.
- •Absence of caries or overflowing restorations and periapical injuries of the target tooth.
- •Non-smokers.
- •Absence of systemic disease.
- •Negative history for pregnancy
- •No relevant medical history that contraindicate periodontal surgery.
- •All participants signed an inform consent form.
- •The participant is female or male adult of ≥ 18 years. The sample in sex will be compensated.
- •The participant is willing and able to return to the treatments and evaluations programmed throughout this clinical study.
排除标准
- •The participant is pregnant or lactating or plans to become pregnant within the next 6 months.
- •Heavy smoker (>10 cigarettes/day).
- •The participant takes> 4 U of alcohol / day.
- •The participant has a chronic illness or decreased mental capacity which would mitigate the ability to comply with the protocol.
- •Taking drugs that could alter the participant's response in healing or with oral concomitant manifestations that, in the opinion of the investigator, could interfere with the assessment of safety or efficacy.
- •Participants with systemic diseases that interfere with treatment such as, Diabetes mellitus, or rheumatoid arthritis.
- •Allergies to drug compounds.
- •The participant has been treated with antibiotics within 3 months before starting the study or has any other systemic condition that requires antibiotic coverage for routine periodontal procedures (eg, heart disease, prosthetic joints, etc.).
- •Participants should not have received periodontal tretment within the 6-month period prior to study.
研究组 & 干预措施
Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML
- The study participants will first undergo SCALE AND ROOT PLANING. This procedure is the same as that used in the active comparator group and the control group.
- Eight weeks following the initial therapy, reevaluation of the intrabony defects in the interproximal sites with a clinical probing depth >5 mm will be performed by radiographs as well as by using William's graduated periodontal probe to confirm the indication for periodontal surgery. Pairs of premolar and molar teeth in the maxilla or the mandible will be randomized to receive the test treatment (REGENERATIVE PERIODONTAL SURGERY with adjunctive hyaluronic acid gel application) or to serve as active comparators (regenerative periodontal surgery with adjunctive enamel matrix derivative application).
干预措施: Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML (Drug)
Enamel Matrix Proteins
- SCALE AND ROOT PLANING
- REGENERATIVE PERIODONTAL SURGERY: Application of enamel matrix derivative.
干预措施: Enamel Matrix Proteins (Active comparator group) (Drug)
Scale and root planning
Control group: Just SCALE AND ROOT PLANING is performed
结局指标
主要结局
Clinical measure: Clinical attachment loss (CAL). Changes will be assessed at 3 time points.
时间窗: 1. Baseline, 2. Reevaluation (60 days after root debridement), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
It is defined as the distance in millimeters between CEJ and the end of the periodontal pocket. The calculation of the depth of the pocket + gingival recession or pocket depth - gingival hyperplasia will be carried out.
次要结局
- Radiographic measure: D1(1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).)
- Radiographic measure: Cemento-enamel junction (A1)(1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).)
- Radiographic measure: B1(1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).)
- Clinical measure: Probing pocket depth (PPD). Changes will be assessed at 3 time points.(1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).)
- Clinical measure: Gingival recession (GR). Changes will be assessed at 3 time points.(1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).)
- Clinical measure: Tooth mobility (TM) Miller (1950). Changes will be assessed at 3 time points.(1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).)
- Clinical measure: Furcation involvement: Hamp (1975). Changes will be assessed at 3 time points.(1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).)
- Clinical measure: Plaque Index (Sillness y Löe 1964). Changes will be assessed at 3 time points.(1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).)
研究者
Andres Lopez Roldan
Assistant Professor with PhD
University of Valencia