Bone Material's Histomorphometric Analysis In Socket Preservation

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Socket Preservation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indywidualna Praktyka Stomatologiczna Marek Śmielecki, Gniezno, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tooth extraction and GBR procedure

Device

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.

Primary outcomes

Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure.

Time frame: 6 months

A new bone formation assesses via histomorphometric evaluation.

Secondary outcomes

Evaluation of (serious) adverse events (S)AEs.

Time frame: 13 months

Number of (S)AEs

Sponsors and collaborators

Lead sponsor

Medical Inventi S.A.

Industry

Registry information

Official study title

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

Acronym: BM-HIS-SP

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Dec 18, 2024
Registry last updated: Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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