Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement

Impact of Alveolar Ridge Preservation on Optimal Implant Placement

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.

Study Overview

• Status: Unknown
• Conditions: Tooth Avulsion
• Intervention / Treatment: Procedure: Tooth extraction and Alveolar ridge preservation; Procedure: Tooth extraction

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PR
    • Parma, PR, Italy, 43126
      • Centro Universitario di Odontoiatria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alveolar Ridge Preservation; 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.	Procedure: Tooth extraction and Alveolar ridge preservation; Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal; Other Names: Socket preservation
Active Comparator: Natural healing; Patients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing.	Procedure: Tooth extraction; Tooth extraction and socket natural healing; Other Names: Socket natural healing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Simone Lumetti
• Collaborators: Geistlich Pharma AG; Dentsply Sirona Implants and Consumables
• Investigators: Study Director: Guido Macaluso, MDS, MSc, University of Parma

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: May 3, 2015
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Tooth extraction; Socket preservation; Single implant
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries; Tooth Avulsion
• Other Study ID Numbers: sockpres-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No