Bone Material's Histomorphometric Analysis In Socket Preservation (BM-HIS-SP)

Medical Inventi S.A.

Status: Active, not recruiting

Conditions: Socket Preservation

Treatments: Device: Tooth extraction and GBR procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT06740110

PC-MD-CIP-003

Details and patient eligibility

About

This is a prospective, multicentre, parallel-group, 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Interventional arm

Experimental group

Description:

The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places investigational device, and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed.

Treatment:

Device: Tooth extraction and GBR procedure

Standard of care arm

Active Comparator group

Description:

The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places standard of care device and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed.

Treatment:

Device: Tooth extraction and GBR procedure