Connective Tissue Graft Versus Collagen Matrix. A 3D Digital Soft Tissue Thickening Analysis in Mucogingival Surgery: a 6 Months Follow-up Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Soft tissue modifications
研究概览
简要总结
Despite the potential role of soft tissue thickness in maintaining gingival margin stability, the existing literature has mainly focused on investigating the effect of different surgical techniques on recession coverage percentage, without taking into account the changes in tissue thickness and biotype in the surgical area. Hence, this study aims to compare threedimensional scans of gingival recessions treated either with CAF+CTG or with CAF+PDCM by the use of a dedicated superimposition software at different healing timepoints.
The primary outcome is to assess the change in mm3 and the distribution pattern of soft tissue thickening in the surgical area between autologous and heterologous grafts at 1, 3, and 6 months post-surgery. The secondary outcomes are: the complete root coverage at 6 months post surgery and Patients' Reported Outcomes (PROMS) measured with oral impact on daily performances (OIDP questionnaire) and on the evaluation of patients' perception about therapy.
详细描述
This is a pilot study and will include 8 visits over a minimum period of 25 weeks. The trial will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement and will be registered in clinicaltrials.gov after the obtainment of the relevant approval from ethics committee. All the relevant authorization (Ethical committee, Insurance) will be obtained before study initiation. Study population: 12 patients will be recruited in the new patient and follow-up clinics which run every week at the Centre of Dentistry of University of Parma.
Main inclusion criteria:
- Systemically healthy males and females ≥ 18 years old
- Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
- Clinical evidence of a single gingival recession (RT1, RT2)
- Full mouth bleeding and plaque scores (FMBS and FMPS) < 20% recorded
- Non-surgical treatment completed within 6 months prior to assessment for eligibility
Main inclusion criteria:
- Medical history that includes diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS).
- Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
- History of alcohol or drug abuse.
- Smoking ≥10 cigarettes a day
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- Taking medications that might induce gingival overgrowth (e.g. calcium antagonists)
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy males and females ≥ 18 years old
- •Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
- •Clinical evidence of a single gingival recession (RT1, RT2)
- •Full mouth bleeding and plaque scores (FMBS and FMPS) < 20% recorded
- •Non-surgical treatment completed within 6 months prior to assessment for eligibility
排除标准
- •Medical history that includes diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS).
- •Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
- •History of alcohol or drug abuse.
- •Smoking ≥10 cigarettes a day
- •Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- •Taking medications that might induce gingival overgrowth (e.g. calcium antagonists)
结局指标
主要结局
Soft tissue modifications
时间窗: 6 months
to analyze and measure the soft tissue thickness modifications in the area of the graft with the three-dimensional superimposition technique. The measurement will be performed in cubic millimeters and the distribution will be analyzed with a colorimetric graphic map. The modifications will be compared between groups and between timepoints with an inter/intra group analysis.
次要结局
- PROMS(6 months)
研究者
Prof Elena Calciolari
Researcher
University of Parma