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

Tooth Avulsion Clinical Trial

Official title:

Impact of Alveolar Ridge Preservation on Optimal Implant Placement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04299750
• Other study ID #: sockpres-13
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2020

Study information

• Verified date: March 2020
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: July 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tooth Avulsion

Intervention

Procedure:
• Tooth extraction and Alveolar ridge preservation
Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal
• Tooth extraction
Tooth extraction and socket natural healing

Locations

Country	Name	City	State
Italy	Centro Universitario di Odontoiatria	Parma	PR

Sponsors (3)

Lead Sponsor	Collaborator
Simone Lumetti	Dentsply Sirona Implants, Geistlich Pharma AG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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