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

A Histomorphometric Analysis of Bone Formation With Two Different Bone Graft Material in Adult Patients Required Socket Preservation After Tooth Extraction

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Socket Preservation
• Intervention / Treatment: Device: Tooth extraction and GBR procedure

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gniezno, Poland, 62-200
    • Indywidualna Praktyka Stomatologiczna Marek Śmielecki
  • Mińsk Mazowiecki, Poland, 05-300
    • Medicare
  • Tychy, Poland, 43-100
    • Stomatologia Niteckie Sp. z o.o.
  • Wroclaw, Poland, 53-030
    • Rafał Dobrakowski Dentysta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; 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.	Device: Tooth extraction and GBR procedure; 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 (first arm) or standard of care (second arm) 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.
Active Comparator: Standard of care arm; 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.	Device: Tooth extraction and GBR procedure; 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 (first arm) or standard of care (second arm) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure.	A new bone formation assesses via histomorphometric evaluation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of (serious) adverse events (S)AEs.	Number of (S)AEs	13 months

Collaborators and Investigators

• Sponsor: Medical Inventi S.A.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Dentistry; Oral Surgical Procedures; Tooth Extraction
• Other Study ID Numbers: PC-MD-CIP-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No