Clinical trial NCT03166475: Ridge Preservation With Provisional Ovoid Pontic
Official title: Ridge Preservation With Provisional Ovoid Pontic: a Randomized and Controlled Clinical-tomographic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Process Atrophy
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized controlled trial of 30 patients from the Faculty of Dentistry of the UFJF was conducted. It was included patients who presented indication of extraction of premolars, canines or incisors. All the thirty patients underwent dental extraction and were randomly divided into three groups according to the study methodology. Plaster casts and Cone-Beam Computed Tomography (CBCT) exams were performed for comparative analysis between sample groups and between study times ( imediate postoperative and four months later).

Detailed description: Thirty consecutive patients who presented at the Dentistry College of Federal University of Juiz de Fora (Brazil) were selected, requiring a single-tooth extraction of premolar, canines or incisors in maxilla. All of the patients included at this study signed a free and informed consent form, agreeing to participate voluntarily in this research. The study was approved by the Research Ethical Committee of the University of Juiz de Fora under the form 1.731.395.

The patients were randomly allocated in three groups according the following treatments:

* Group 1: Closure of the socket by primary intention through a palatal pedicle subepithelial connective tissue flap by the technique of Khoury \& Happe (2000) (Figure 1);
* Group 2: Filling the socket with a synthetic bone substitute of biphasic calcium phosphate (Bone Ceramic®, Straumann) and covering it with a palatal pedicle flap by the technique of Khoury \& Happe (2000) (Figure 2);
* Group 3: Sealing of the socket with a provisional ovoid pontic of acrylic resin (Figure 3).

As response factors were performed evaluations of study casts and tomographic analysis for dimensional stability evaluation of the sockets at immediate postoperative and after four months of the surgical procedures.

Eligibility criteria: Inclusion Criteria:

* Patients with indication of extraction of premolars, canines or incisors, which has two adjacent teeth, due to root fracture, extensive caries that did not allow unfavorable restorative and / or endodontic prognosis, systemically healthy.

Exclusion Criteria:

* Patients who use any drug that influences bone metabolism, patients with a history of head radiotherapy and neck, patients undergoing chemotherapy for the treatment of malignant tumors at the time of the study, patients with socket severely reabsorbed, smokers and pregnant women.

Primary outcomes:
measure: Changes of bone remodelation measured by Cone-Beam Computed Tomography exams and by plaster casts analysis, from baseline to 4 months
timeFrame: Baseline (immediate postoperative) and 4 months after it.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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