Status:
UNKNOWN
Does the Non-surgical Application of Enamel Matrix Derivative Reduce the Need of Periodontal Surgical Intervention in Subjects With Severe (Stage III) Periodontitis?
Lead Sponsor:
University of Pisa
Conditions:
Periodontal Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Periodontal treatment relies on a sequential series of different phases that are usually incapsulated in three main phases: non-surgical treatment, surgical phase and, finally, supportive phase. Whils...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Accept the form of the study and signs a declaration of informed consent; understand and are willing, able and likely to comply with all study procedures and restrictions.
- Systemically healthy (according to exclusion criteria 4) participants of either genders who are attending a periodontal centre for periodontal care.
- Aged 18 or over.
- Presenting at least 20 teeth (excluded wisdom teeth).
- Being affected by generalized Periodontitis (stage III) irrespectively of the grade (Tonetti et al., 2018) i.e. presenting at least 5 mm of clinical atattachment loss at the interdental areas, radiographic bone resorption of more than 30% of the root length extending to at least the middle portion of the root, less than 5 teeth lost for periodontal reason, presenting characteristics for complexity (intrabony defects, furcation defects, moderate ridge defects)
- Bleeding on probing on at least 30% of the sites and a minimum of 4 teeth with at least one site with PPD ≥6mm
- Exclusion Criteria:
- Persons incapable of responding to the questions.
- An employee of the sponsor, employee of the general dental practice, and/or a family relative of the employees mentioned above.
- Women known to be pregnant or lactating (a specific declaration form will be signed by the patient, stating the non-pregnant or lactating status).
- Persons suffering of pathologies known to affect the outcome of periodontal therapy (i.e. diabetes, osteoporosis, immunosuppression).
- Persons undergoing therapy which will may complicate adherence to protocol or showing an impact on periodontal outcome (i.e. chemotherapy and immunosuppressive treatments).
- Persons who require antibiotic coverage (following infectious endocarditis, using prosthetic cardiac valves, other pathologies).
- Persons undergoing pharmacological treatment associated with gingival hypertropia development (phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine).
- Persons with implant-supported restorations affected by peri-implantitis (as defined by the 2017 Classification, i.e. presence of bleeding and/or suppuration on gentle probing, probing depths of ≥6 mm, bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant).
- Smokers declaring to smoke more than 20 cigarettes per day.
- Persons with Body Mass Index above 29(obese subjects).
- Anyone who in the investigators' opinion is not suitable to take part in the study.
- Allergy/idiosyncrasy to anaesthesia or components of the device object of the study.
- Previous periodontal subgingival instrumentation within the previous 12 months.
- Antibiotics intake in the previous 3 months.
Exclusion
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05418621
Start Date
March 1 2021
End Date
June 1 2025
Last Update
November 3 2022
Active Locations (2)
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1
University Hospital of Pisa
Pisa, Italy, 56121
2
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy