Back to resultsImpact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement
Primary Purpose
Tooth Avulsion
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tooth extraction and Alveolar ridge preservation
Tooth extraction
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Avulsion focused on measuring Socket preservation, Single implant, Tooth extraction
Eligibility Criteria
Inclusion Criteria:
at least 18 years of age
- at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession;
- adequate oral hygiene, i.e. plaque index score ≤10%;
- mesial-distal width of inter-dental space ≥7 mm;
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) score ≥III
- presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing
- a history of radiotherapy to the head and neck region
- presence of conditions requiring chronic use of antibiotics
- medical conditions requiring prolonged use of steroids
- history of leucocyte dysfunction
- history of bleeding disorders
- history of renal failure
- patients with metabolic bone disorders
- patients with uncontrolled endocrine disorders
- disability affecting oral hygiene
- alcohol or drug abuse
- HIV infection
- smoking >10 cigarettes a day or cigar equivalents
- conditions or circumstances that would prevent completion of study participation
- mucosal diseases
- presence of osseous lesions
- severe bruxing or clenching habits
- persistent intraoral infections
- compromised alveolus (dehiscence, etc)
Sites / Locations
- Centro Universitario di Odontoiatria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alveolar Ridge Preservation
Natural healing
Arm Description
Patients in this arm will undergo atraumatic extraction of an hopeless tooth and a socket preservation procedure. Alveolar ridge preservation will be performed using a slow-resorption bone substitute and a collagen membrane that covers the graft.
Patients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing.
Outcomes
Primary Outcome Measures
Number of implants ideally placed
The main goal is to determine if alveolar ridge preservation affects optimal implant positioning. This is defined as the implant position allowing to fulfill the ideal prosthetic design of the crown to be restored.
Secondary Outcome Measures
Peri-implant bone variation
Crestal bone levels (CBL): distances from the implant shoulder to the most coronal bone to implant contact measured on X-rays with a millimeter ruler to the nearest 0.5 mm. Two measurements will be taken for each implant: mesially and distally
Ridge volume at 6 months after tooth extraction
The comparison of baseline and control cone.beam computed tomography and of clinical data in test and control groups will allow to determine volumetric effects on bone and soft tissues of socket preservation.
Full Information
NCT ID
NCT04299750
First Posted
May 3, 2015
Last Updated
March 4, 2020
Sponsor
Simone Lumetti
Collaborators
Dentsply Sirona Implants and Consumables, Geistlich Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT04299750
Brief Title
Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement
Official Title
Impact of Alveolar Ridge Preservation on Optimal Implant Placement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Simone Lumetti
Collaborators
Dentsply Sirona Implants and Consumables, Geistlich Pharma AG
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.
Detailed Description
The main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. Bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Avulsion
Keywords
Socket preservation, Single implant, Tooth extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alveolar Ridge Preservation
Arm Type
Experimental
Arm Description
Patients in this arm will undergo atraumatic extraction of an hopeless tooth and a socket preservation procedure. Alveolar ridge preservation will be performed using a slow-resorption bone substitute and a collagen membrane that covers the graft.
Arm Title
Natural healing
Arm Type
Active Comparator
Arm Description
Patients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing.
Intervention Type
Procedure
Intervention Name(s)
Tooth extraction and Alveolar ridge preservation
Other Intervention Name(s)
Socket preservation
Intervention Description
Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal
Intervention Type
Procedure
Intervention Name(s)
Tooth extraction
Other Intervention Name(s)
Socket natural healing
Intervention Description
Tooth extraction and socket natural healing
Primary Outcome Measure Information:
Title
Number of implants ideally placed
Description
The main goal is to determine if alveolar ridge preservation affects optimal implant positioning. This is defined as the implant position allowing to fulfill the ideal prosthetic design of the crown to be restored.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Peri-implant bone variation
Description
Crestal bone levels (CBL): distances from the implant shoulder to the most coronal bone to implant contact measured on X-rays with a millimeter ruler to the nearest 0.5 mm. Two measurements will be taken for each implant: mesially and distally
Time Frame
6 months
Title
Ridge volume at 6 months after tooth extraction
Description
The comparison of baseline and control cone.beam computed tomography and of clinical data in test and control groups will allow to determine volumetric effects on bone and soft tissues of socket preservation.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
at least 18 years of age
at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession;
adequate oral hygiene, i.e. plaque index score ≤10%;
mesial-distal width of inter-dental space ≥7 mm;
Exclusion Criteria:
American Society of Anesthesiologists (ASA) score ≥III
presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing
a history of radiotherapy to the head and neck region
presence of conditions requiring chronic use of antibiotics
medical conditions requiring prolonged use of steroids
history of leucocyte dysfunction
history of bleeding disorders
history of renal failure
patients with metabolic bone disorders
patients with uncontrolled endocrine disorders
disability affecting oral hygiene
alcohol or drug abuse
HIV infection
smoking >10 cigarettes a day or cigar equivalents
conditions or circumstances that would prevent completion of study participation
mucosal diseases
presence of osseous lesions
severe bruxing or clenching habits
persistent intraoral infections
compromised alveolus (dehiscence, etc)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Macaluso, MDS, MSc
Organizational Affiliation
University of Parma
Official's Role
Study Director
Facility Information:
Facility Name
Centro Universitario di Odontoiatria
City
Parma
State/Province
PR
ZIP/Postal Code
43126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement
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