Treatment of Intraosseous Periodontal Defects With Amelogenins

Federico II University22 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periodontal Bone Loss Periodontal Pocket

Interventions

MINSD and amelogeninsOTHER

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.

MINSDOTHER

Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Naples Federico II

Naples, Italy

RECRUITING

Outcomes

Primary Outcomes

Change of Clinical Attachment Level (CAL) gain (millimeters)

Distance from the cementoenamel junction to the bottom of the pocket

Time frame: baseline and 6 months after periodontal therapy

Secondary Outcomes

Change of Probing Depth (PD) (millimeters)

Distance from the gingival margin to the bottom of the pocket

Time frame: baseline and 6 months after periodontal therapy

Change of Gingival Recession (GR) (millimeters)

Distance from gingival margin to the cementoenamel junction

Time frame: baseline and 6 months after periodontal therapy

Change of Radiographic Defect Angle (RDA) (grade °)

Radiographic intraosseous angle

Time frame: baseline and 6 months after periodontal therapy

Central Contacts

Luca Ramaglia

CONTACT

+393476912911 luca.ramaglia@unina.it

Data from ClinicalTrials.gov

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