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Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation

Primary Purpose

Alveolar Bone Loss

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Extraction site development technique
autogenous tooth bone graft
Socket seal technique
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring alveolar ridge preservation, autogenous tooth bone graft, extraction side development technique

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Women and men Patients over 18 years Co-operative patients with good individual oral hygiene (FMBS: 25%>) Patients with periodontal disease in treatment or under treatment with minimal active inflammation (FMPS: 25%>) Local criteria: Teeth with a hopeless prognosis with advanced periodontal or endo-periodontal defects, which are restored with implant prosthesis EDS 3-4 extraction defects after tooth extraction Exclusion Criteria: Infectious diseases (HBV, HCV, HIV, CoV-2019…) Current chemotherapy or radiotherapy Previous radiation therapy to the head and neck region (in the last 2 years) Untreated insulin dependent diabetes mellitus Clinically significant osteoporosis or other systemic disease affecting bone metabolism Clinically significant circulatory disorder e.g.: decompensated cardiac failure Haemodynamically significant valvular heart failure or myocardial infarction within the last 3 months Clinically significant coagulopathy Current or previous systemic corticosteroid therapy (in the last 2 months) Current or previous systemic bisphosphonate therapy (beyond 30 days) Pregnant or breastfeeding women Smoking (max 5 cigarettes per day) Drug addiction, alcoholism

Sites / Locations

  • Semmelweis University Department of PeriodontologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

socket seal group

XSD+ socket seal group

XSD+ ATB+socket seal group

Arm Description

After tooth extraction a soft tissue pounch is sutured above the extraction socket.

After tooth extraction for the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.

After tooth extraction, the tooth will be grinded and after the sterilization procedure it will be filled back to the extraction socket. For the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.

Outcomes

Primary Outcome Measures

Horizontal ridge width changes
The primary outcome is the alveolar ridge width change in millimeter intraoperatively, measured immediately after the tooth extraction and after 6 months at the reentry procedure (at the time of implant placement).

Secondary Outcome Measures

Evaluation of change of alveolar ridge width on CBCT
Alveolar ridge width measured at baseline and 6 months postoperatively on CBCT data sets
Evaluation of change of alveolar ridge height on CBCT
Alveolar ridge height measured at baseline and 6 months postoperatively on CBCT data sets
Evaluation of change of alveolar ridge volume on CBCT
Alveolar ridge volumetric changes measured at baseline and 6 months postoperatively on CBCT data sets
Monitoring the microvascularization
Monitoring of gingival microvascularization, monitoring of flap revascularization by Laser Speckle Contrast Imaging
Examination of early wound healing phase
Examination of early wound healing phase by means of clinical photdocumentation
Soft tissue volumetric changes
Assessment of soft tissue volumetric changes by intraoral scanning
Histomorphometry
Histomorphometric evaluation of the volumetric percentage of newly formed bone, connective tissue and graft material after a 6-month healing period in a core biopsy taken at the time of implant placement

Full Information

First Posted
November 16, 2022
Last Updated
December 30, 2022
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT05674331
Brief Title
Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation
Official Title
Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Hard- and Soft- Tissue Changes Following Alveolar Ridge Preservation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
With alveolar ridge preservation (ARP) ridge resorption following extraction may be reduced. Several materials and techniques have been advocated for ARP. The aim of our randomised clinical trial is to evaluate the efficacy of extraction side development technique (XSD) and autogenous tooth bone graft (ATB) for ARP.
Detailed Description
A three armed clinical study will be established. According to the sample size calculation, every arm will contain 21 participants. The first group is the socket seal group. In the second group we aim to combine the socket seal and XSD technique. In the third group the XSD technique will be combined with the ATB material. The primary outcome is the alveolar ridge width change in millimeter, measured immediately after the tooth extraction and after 6 months at the reentry procedure. The change in alveolar ridge width and vertical dimensional alterations will be also measured as secondary outcomes on the CBCT at baseline and after 6 months. Further secondary outcomes are the monitoring of gingival microvascularization, monitoring of flap revascularization by Laser Speckle Contrast Imaging and assessment of soft tissue volumetric changes by intraoral scanning and histomorphometric evaluation of the volumetric percentage of newly formed bone, connective tissue and graft material after a 6-month healing period in a core biopsy taken at the time of implant placement. Hypothesis: The XSD and XSD+ATB groups are expected to have less pronounced horizontal width losses. XSD group is expected to produce the highest graft turnover.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
alveolar ridge preservation, autogenous tooth bone graft, extraction side development technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
socket seal group
Arm Type
Active Comparator
Arm Description
After tooth extraction a soft tissue pounch is sutured above the extraction socket.
Arm Title
XSD+ socket seal group
Arm Type
Experimental
Arm Description
After tooth extraction for the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.
Arm Title
XSD+ ATB+socket seal group
Arm Type
Experimental
Arm Description
After tooth extraction, the tooth will be grinded and after the sterilization procedure it will be filled back to the extraction socket. For the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.
Intervention Type
Procedure
Intervention Name(s)
Extraction site development technique
Other Intervention Name(s)
XSD
Intervention Description
The technique is described by Molnar et al. in 2019. The aim is to reconstruct the buccal bony wall with a xenogenic membrane with a slow absorption rate properties. This technique aims to stabilizate and enlarge the blood clot .
Intervention Type
Device
Intervention Name(s)
autogenous tooth bone graft
Other Intervention Name(s)
ATB
Intervention Description
ATB was invented by Kim et al. in 2011. The extracted tooth is grinded and goes throw a sterilization procedure by the manufacturer's recommendation. The graft material can be used immediately for ARP.
Intervention Type
Procedure
Intervention Name(s)
Socket seal technique
Intervention Description
After tooth removal neither graft nor any membrane material is inserted to the extraction socket. A soft tissue pounch is harvested from the hard palate and it is fixed above the extraction socket with single interrupted sutures.
Primary Outcome Measure Information:
Title
Horizontal ridge width changes
Description
The primary outcome is the alveolar ridge width change in millimeter intraoperatively, measured immediately after the tooth extraction and after 6 months at the reentry procedure (at the time of implant placement).
Time Frame
during first surgery and during 6 months reentry
Secondary Outcome Measure Information:
Title
Evaluation of change of alveolar ridge width on CBCT
Description
Alveolar ridge width measured at baseline and 6 months postoperatively on CBCT data sets
Time Frame
at baseline and 6 months postoperatively
Title
Evaluation of change of alveolar ridge height on CBCT
Description
Alveolar ridge height measured at baseline and 6 months postoperatively on CBCT data sets
Time Frame
at baseline and 6 months postoperatively
Title
Evaluation of change of alveolar ridge volume on CBCT
Description
Alveolar ridge volumetric changes measured at baseline and 6 months postoperatively on CBCT data sets
Time Frame
at baseline and 6 months postoperatively
Title
Monitoring the microvascularization
Description
Monitoring of gingival microvascularization, monitoring of flap revascularization by Laser Speckle Contrast Imaging
Time Frame
Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.
Title
Examination of early wound healing phase
Description
Examination of early wound healing phase by means of clinical photdocumentation
Time Frame
Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.
Title
Soft tissue volumetric changes
Description
Assessment of soft tissue volumetric changes by intraoral scanning
Time Frame
analysis of baseline and 6-month post-alveolar digital impressions
Title
Histomorphometry
Description
Histomorphometric evaluation of the volumetric percentage of newly formed bone, connective tissue and graft material after a 6-month healing period in a core biopsy taken at the time of implant placement
Time Frame
6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women and men Patients over 18 years Co-operative patients with good individual oral hygiene (FMBS: 25%>) Patients with periodontal disease in treatment or under treatment with minimal active inflammation (FMPS: 25%>) Local criteria: Teeth with a hopeless prognosis with advanced periodontal or endo-periodontal defects, which are restored with implant prosthesis EDS 3-4 extraction defects after tooth extraction Exclusion Criteria: Infectious diseases (HBV, HCV, HIV, CoV-2019…) Current chemotherapy or radiotherapy Previous radiation therapy to the head and neck region (in the last 2 years) Untreated insulin dependent diabetes mellitus Clinically significant osteoporosis or other systemic disease affecting bone metabolism Clinically significant circulatory disorder e.g.: decompensated cardiac failure Haemodynamically significant valvular heart failure or myocardial infarction within the last 3 months Clinically significant coagulopathy Current or previous systemic corticosteroid therapy (in the last 2 months) Current or previous systemic bisphosphonate therapy (beyond 30 days) Pregnant or breastfeeding women Smoking (max 5 cigarettes per day) Drug addiction, alcoholism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleonora Solyom, DMD
Phone
0036304636885
Email
eleonorasolyom@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Palkovics, DMD
Phone
0036308940408
Email
dpalkovics@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balint Molnar
Organizational Affiliation
Department of Periodontology,Semmelweis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University Department of Periodontology
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleonora Solyom, DMD
Phone
0036304636885
Email
eleonorasolyom@gmail.com
First Name & Middle Initial & Last Name & Degree
Balint Molnar, DMD, PhD
Phone
0036302553334
Email
molbal81@gmail.com
First Name & Middle Initial & Last Name & Degree
Balint Molnar, DMD, Phd
First Name & Middle Initial & Last Name & Degree
Eleonora Solyom, DMD
First Name & Middle Initial & Last Name & Degree
Reka Fazekas, DMD, PhD
First Name & Middle Initial & Last Name & Degree
Daniel Palkovics, DMD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation

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