Treatment of Intraosseous Periodontal Defects With Amelogenins

Federico II University

Status: Enrolling

Conditions: Periodontal Pocket; Periodontal Bone Loss

Treatments: Other: MINSD; Other: MINSD and amelogenins

Study type: Interventional

Funder types: Other

Identifiers

NCT05315804

477/21

Details and patient eligibility

About

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).

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Amelogenin Group (A)

Experimental group

Description:

Amelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)

Treatment:

Other: MINSD and amelogenins

No-amelogenin Group (B)

Active Comparator group

Description:

Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed

Treatment:

Other: MINSD