Bone Material's Histomorphometric Analysis In Socket Preservation

Not Applicable

Not yet recruiting

• Conditions: Socket Preservation

• Registration Number: NCT06740110
• Lead Sponsor: Medical Inventi S.A.

Brief Summary

This prospective, multicentre, split-mouth randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after tooth extraction.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Start: 2025-03-12
• Primary Completion: 2026-07-05
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients over 18 years old with full legal capacity, male and female;
• Patients with ability to understand the proposed surgical treatment and to understand and sign the informed consent;
• Patients who are willing and able to comply with scheduled visits, treatment and other trial procedures;
• Patients who respect the follow-up recalls.

Exclusion Criteria

• Presence of bone lesions;
• Patients with alcohol or substance abuse;
• Patients with smoking habits (more than 10 cigarettes per day);
• Patients presenting physical and/or mental handicap that impede an adequate oral hygiene;
• Pregnant or breast feeding women;
• Patients currently participating in any other clinical investigation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure.	6 months	A new bone formation assesses via histomorphometric evaluation.

Secondary Outcome Measures

Name	Time	Method
Evaluation of (serious) adverse events (S)AEs.	13 months	Number of (S)AEs