Clinical trial NCT05315804: Treatment of Intraosseous Periodontal Defects With Amelogenins
Official title: Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Amelogenins. A Randomized-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Bone Loss
Periodontal Pocket
Keywords: Amelogenin
Periodontal Therapy
Periodontal Bone Loss
Intraosseous Bone Defect
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Clinical Attachment Level (CAL) gain (millimeters)
timeFrame: baseline and 6 months after periodontal therapy
Secondary outcomes:
measure: Change of Probing Depth (PD) (millimeters)
timeFrame: baseline and 6 months after periodontal therapy
measure: Change of Gingival Recession (GR) (millimeters)
timeFrame: baseline and 6 months after periodontal therapy
measure: Change of Radiographic Defect Angle (RDA) (grade °)
timeFrame: baseline and 6 months after periodontal therapy
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: Federico II University
name: Luca Ramaglia
role: PRINCIPAL_INVESTIGATOR
References: