Using a non-surgical treatment to reduce the need for surgery in severe gum disease
Does the Non-surgical Application of Enamel Matrix Derivative Reduce the Need of Periodontal Surgical Intervention in Subjects With Severe (Stage III) Periodontitis? A Randomized, Multicenter, Clinical Trial
PHASE3 · University of Pisa · NCT05418621
This study is testing if a special gel can help people with severe gum disease avoid surgery by improving their gum health.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pisa (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Pisa and 1 other locations) |
| Trial ID | NCT05418621 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether the application of Enamel Matrix Derivative can effectively reduce the need for surgical intervention in patients with severe periodontitis. The study involves non-surgical periodontal treatment, which is a key component in managing periodontitis, and aims to assess the efficacy of this treatment compared to a saline application. Participants will be monitored for improvements in clinical attachment loss and other periodontal health indicators. The trial is designed to provide insights into alternative treatment options for patients who may not be suitable for surgery.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults aged 18 or older with generalized stage III periodontitis and specific clinical characteristics.
Not a fit: Patients with advanced periodontal disease requiring immediate surgical intervention or those with systemic health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for managing severe periodontitis, potentially improving patient outcomes and reducing the need for surgical procedures.
How similar studies have performed: Previous studies have shown that non-surgical treatments can be effective in managing periodontal diseases, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pisa and 1 other locations
- University Hospital of Pisa — Pisa, Italy (RECRUITING)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Periodontal Diseases