Treatment of Intraosseous Periodontal Defects With Amelogenins

Not Applicable

Recruiting

• Conditions: Periodontal Pocket; Periodontal Bone Loss
• Interventions: Other: MINSD and amelogenins; Other: MINSD

• Registration Number: NCT05315804
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2023-02-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-07-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amelogenin Group (A)	MINSD and amelogenins	Amelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)
No-amelogenin Group (B)	MINSD	Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy