Treatment of Intraosseous Periodontal Defects With Amelogenins

Periodontal Pocket Clinical Trial

Official title:

Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Amelogenins. A Randomized-controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315804
• Other study ID #: 477/21
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: Luca Ramaglia
• Phone: +393476912911
• Email: luca.ramaglia[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Bone Loss
• Periodontal Pocket

Intervention

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

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Clinical Attachment Level (CAL) gain (millimeters)	Distance from the cementoenamel junction to the bottom of the pocket	baseline and 6 months after periodontal therapy
Secondary	Change of Probing Depth (PD) (millimeters)	Distance from the gingival margin to the bottom of the pocket	baseline and 6 months after periodontal therapy
Secondary	Change of Gingival Recession (GR) (millimeters)	Distance from gingival margin to the cementoenamel junction	baseline and 6 months after periodontal therapy
Secondary	Change of Radiographic Defect Angle (RDA) (grade °)	Radiographic intraosseous angle	baseline and 6 months after periodontal therapy