Polynucleotide and Hyaluronic Acid-based Gel as Adjunctive Therapy to Non- Surgical Treatment of Intraosseous Peri-implant Defect. A 6-month Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Probing pocket depth
研究概览
简要总结
This randomized, placebo-controlled clinical trial evaluates the efficacy of a polynucleotide and hyaluronic acid-based gel (PN-HA) as adjunctive therapy to non-surgical flapless treatment of peri-implantitis. The main goal is to assess probing pocket depth (PPD) reduction after 6 months compared to placebo.
Study Design:
- Type: Interventional (Clinical Trial)
- Allocation: Randomized (computer-generated blocks)
- Intervention Model: Parallel assignment
- Masking: Single-blind (examiner-blinded)
- Primary Purpose: Treatment
- Estimated Enrollment: 32 participants
- Duration: 6 month follow-up
详细描述
Study design This study will be a randomized controlled, clinical trial with 6 months follow-up.
Participants:
Subjects eligible for the study will be identified from patients referred to the Clínica Universitària d'Odontologia - UIC Barcelona at the Periodontology Department. All study subjects will provide written informed consent before participating in the study.
Inclusion criteria: ≥18 years old, ≥1 implant with peri-implantitis and intraosseous defect ≥3mm, good oral hygiene, modifiable prosthesis.
Exclusion criteria: systemic diseases, pregnancy, recent antibiotic use, smoking >10 cigarettes/day, poor plaque control, implant mobility.
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 (Investigator, Outcomes Assessor)
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
- •Subjects with (I) ≥ 18 years of age, the presence of at least one implant diagnosed with peri-implantitis, intraosseous ≥ 3mm defects, presence of screw-retained single-unit crowns and partial dental prosthesis that allowed correct access for brushing; and, if not, prostheses that could be modified.
排除标准
- •Subjects will be excluded from the study if they had received previous non-surgical peri-implantitis treatment during the last 6 months or surgical treatment, were pregnant or breast-feeding, had received antibiotic treatment in the previous 3 months, had systemic conditions that contraindicated treatment, smoking more than 10 cigarettes/day or presents a poor plaque control (Plaque Index < 20%), implant mobility.
研究组 & 干预措施
non-surgical therapy
Standardized peri-implant non-surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing)
干预措施: Non-Surgical Intervention (Procedure)
Test group: adjunctive PN-HA gel
Standardized peri-implant non.surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing). At the end of the peri-implant non-surgical therapy a viscoelastic gel containing a fixed combination of natural origin PN (10 mg/ml, 1%) and HA with molecular weight > 1500 kDa (10 mg/ml, 1%) (REGENFASTe, Mastelli S.r.l., Sanremo, Italy) will be injected in the peri-implant sulcus.
干预措施: viscoelastic gel containing a fixed combination of natural origin PN (10 mg/ml, 1%) and HA with molecular weight > 1500 kDa (10 mg/ml, 1%) (Other)
Test group: adjunctive PN-HA gel
Standardized peri-implant non.surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing). At the end of the peri-implant non-surgical therapy a viscoelastic gel containing a fixed combination of natural origin PN (10 mg/ml, 1%) and HA with molecular weight > 1500 kDa (10 mg/ml, 1%) (REGENFASTe, Mastelli S.r.l., Sanremo, Italy) will be injected in the peri-implant sulcus.
干预措施: Non-Surgical Intervention (Procedure)
结局指标
主要结局
Probing pocket depth
时间窗: Baseline , 3 months, 6 months
Peri-implant pocket depth: distance (mm) from the mucosal margin to the base of the probable pocket.
次要结局
- Modified plaque index(Baseline , 3 months, 6 months)
- Modified bleeding index(Baseline , 3 months, 6 months)
- Bleeding on porbing(Baseline , 3 months, 6 months)
- Angulation of the intra-bony defect(Baseline , 3 months, 6 months)
- Serum levels of IL-1β, IL-8, and TNF-α(Baseline , 14 days)
- Keratinized mucosa width(Baseline , 3 months, 6 months)
- Bone level(Baseline , 3 months, 6 months)
- Intra-bony defect width(Baseline , 3 months, 6 months)
- Presence and numbers of Aggregatibacter actinomycetemcomitans, Porhyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Parvimonas micra, Fusobacterium nucleatum, Campylobacter rectus and Treponema denticola(Baseline , 14 days)
- Pain of the patients(baseline, after non surgical therapy, 14 days.)