Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft Versus Autogenous Bone Graft in Management of Periodontal Intrabony Defects Using Modified Minimally Invasive Surgical Technique: A Non-Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Clinical attachment level (CAL) gain change from baseline to 6 months.
研究概览
简要总结
The main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects.
The main question is: In periodontitis patients with intrabony defects, will using autogenous demineralized dentin as bone graft substitute result in clinical attachment gain and linear bone fill similar to autogenous bone graft following modified minimally invasive surgical technique? After enrolment, each participant with intra-bony defects will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any.
After 4-6 weeks, an individually customized positioning stent will be fabricated for each participant and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements.
Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD (Probing depth) ≥ 5 mm, CAL (Clinical attachment loss) ≥ 4 mm.
Surgical procedures will include flap elevation for approaching the defect-associated sites using the modified minimally invasive surgical technique (M-MIST).
Intervention group: The defect will be filled with autogenous demineralized dentin graft prepared from the participant's freshly extracted own teeth.
Control group: The defect will be filled with autogenous bone graft harvested from the retromolar area.
For both groups, flaps will be approximated and sutured at the original position. All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months and after 6 months.
详细描述
Research objective: The aim of conducting this research is the development of a newer, less invasive and cost-effective therapeutic approaches that help in management of periodontal intrabony defects. Due to the shortcomings of other bone substitute materials, another bone substitute material that would be completely autogenous and cost-effective is required. Grafting autogenous demineralized dentin has been used extensively for socket preservation and showed promising results in addition to being cost-effective.
Research Procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University.
Eligibility criteria:
I. Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient-related criteria:
- •Motivated patient 18 years of age or order.
- •Patient consulting in the outpatient clinic.
- •Patient ready to perform oral hygiene instructions.
- •Provide informed consent.
- •Accepts the 6 months follow-up period.
- •Teeth related criteria:
- •Tooth with two or three-walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
- •Mature permanent tooth.
- •Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or supernumerary tooth to be extracted and used as whole tooth graft inside the intrabony defect.
排除标准
- •Patient-related criteria:
- •Medically compromised patients.
- •Pregnant women.
- •Uncooperative patients.
- •Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism).
- •Failure to maintain good oral hygiene.
- •Teeth related criteria:
- •Teeth with supra-bony defects.
- •Teeth with grade III mobility.
- •Teeth having interproximal craters, grade III furcation involvement, and grade III mobility.
- •Presence of caries or overhanging restorations.
- •Presence of peri-apical injuries.
结局指标
主要结局
Clinical attachment level (CAL) gain change from baseline to 6 months.
时间窗: CAL gain will be taken at baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.
The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements.
次要结局
- Linear bone fill change from baseline to 6 months(Linear bone fill will be measured at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner)
- Gingival index (GI) change from baseline to 6 months(GI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner)
- Gingival recession (GR) change from baseline to 6 months(GR will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.)
- Bleeding on probing (BoP) change from baseline to 6 months(BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.)
- Probing pocket depth (PPD) change from baseline to 6 months(PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.)
- Patient satisfaction(Patient satisfaction will be measured 2 weeks post-surgical.)
- Plaque index (PI) change from baseline to 6 months(PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner)
- Postoperative Pain(Postoperative Pain will be measured after the surgical procedure and 2 weeks post-surgical.)
研究者
Ghada Mohamed Ali Hussein Abouhussein
Master Degree student, Periodontology department, Faculty of Dentistry, Cairo University
Cairo University