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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tooth Avulsion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Tooth extraction and Alveolar ridge preservation

Intervention Type PROCEDURE

Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal

Natural healing

Patients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing.

Group Type ACTIVE_COMPARATOR

Tooth extraction

Intervention Type PROCEDURE

Tooth extraction and socket natural healing

Interventions

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Tooth extraction and Alveolar ridge preservation

Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal

Intervention Type PROCEDURE

Tooth extraction

Tooth extraction and socket natural healing

Intervention Type PROCEDURE

Other Intervention Names

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Socket preservation Socket natural healing

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes