Bone Material's Histomorphometric Analysis In Socket Preservation

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06740110

Acronym

BM-HIS-SP

Enrollment

Registered

2024-12-18

Start date

2025-10-01

Completion date

2027-01-30

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Socket Preservation

Brief summary

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.

Interventions

DEVICETooth 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026