Periodontal Bone Loss, Periodontal Pocket
Conditions
Keywords
Amelogenin, Periodontal Therapy, Periodontal Bone Loss, Intraosseous Bone Defect
Brief summary
The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins, compared to MINSD alone. A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).
Detailed description
The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins compared to MINSD alone. Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group). Primary outcome will be Clinical Attachment Level (CAL) gain, while the secondary outcomes will be Probing Depth (PD), Gingival Recession (GR) and Radiographic Defect Angle (RDA). After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous periodontal pockets using a sterile syringe with plasticized needle. In the B group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette. Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.
Interventions
OTHERMINSD and amelogenins
After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied to the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
OTHERMINSD
Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
Intervention model description
The study will be designed as a double-arm randomized controlled clinical trial. The intraosseous defects of subjects allocated in A group will be treated with MINSD and application of amelogenins in gel, while in B Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients diagnosed with periodontitis; * Age ≥ 18 years old; * Presence of at least 10 teeth per arch; * Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant; * Presence of at least one intraosseous pocket; * Single-rooted and multi-rooted teeth.
Exclusion criteria
* Patients with systemic diseases; * Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy; * Pregnant or lactating; * Tobacco smokers (≥ 10 cigarettes per day); * Multi-rooted teeth with furcation involvement; * Third molars.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Clinical Attachment Level (CAL) gain (millimeters) | baseline and 6 months after periodontal therapy | Distance from the cementoenamel junction to the bottom of the pocket |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Probing Depth (PD) (millimeters) | baseline and 6 months after periodontal therapy | Distance from the gingival margin to the bottom of the pocket |
| Change of Gingival Recession (GR) (millimeters) | baseline and 6 months after periodontal therapy | Distance from gingival margin to the cementoenamel junction |
| Change of Radiographic Defect Angle (RDA) (grade °) | baseline and 6 months after periodontal therapy | Radiographic intraosseous angle |
Countries
Italy
Contacts
Primary ContactLuca Ramaglia
Outcome results
None listed