Treatment of Intraosseous Periodontal Defects With Amelogenins

NCT05315804 | Recruiting DMC

• 1 other identifier: 477/21
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Periodontal Bone Loss; Periodontal Pocket

Keywords

Amelogenin; Periodontal Therapy; Periodontal Bone Loss; Intraosseous Bone Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of Probing Depth (PD) (millimeters)

  baseline and 6 months after periodontal therapy

• Change of Gingival Recession (GR) (millimeters)

  baseline and 6 months after periodontal therapy

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

  baseline and 6 months after periodontal therapy

Study Arms (2)

Amelogenin Group (A)

EXPERIMENTAL

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

Other: MINSD and amelogenins

No-amelogenin Group (B)

ACTIVE COMPARATOR

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

Other: MINSD

Interventions

MINSD and amelogenins OTHER

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.

Amelogenin Group (A)

MINSD OTHER

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

No-amelogenin Group (B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontal Pocket

Interventions

Amelogenin

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Dental Enamel Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Luca Ramaglia

  Federico II University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Ramaglia

CONTACT

+393476912911; luca.ramaglia@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: February 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)