NCT06740110

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Oct 2025

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Oct 2025Jan 2027

First Submitted

Initial submission to the registry

December 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

January 30, 2026

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

December 12, 2024

Last Update Submit

January 28, 2026

Conditions

Socket Preservation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    13 months

Study Arms (2)

Interventional arm

EXPERIMENTAL

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

Standard of care arm

ACTIVE COMPARATOR

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

Interventions

Tooth extraction and GBR procedureDEVICE

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.

Interventional armStandard of care arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Indywidualna Praktyka Stomatologiczna Marek Śmielecki

Gniezno, 62-200, Poland

Location

Medicare

Mińsk Mazowiecki, 05-300, Poland

Location

Stomatologia Niteckie Sp. z o.o.

Tychy, 43-100, Poland

Location

Rafał Dobrakowski Dentysta

Wroclaw, 53-030, Poland

Location

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 18, 2024

Study Start

October 1, 2025

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

January 30, 2026

Record last verified: 2025-06

Locations

PL(4)