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Ridge Preservation With Provisional Ovoid Pontic

Primary Purpose

Alveolar Process Atrophy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgical procedures
Sponsored by
Federal University of Juiz de Fora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Process Atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Palatal pedicle flap (Group 1)

    Graft + palatal pedicle flap (Group 2)

    Provisional ovoid pontic (Group 3)

    Arm Description

    On patients of this group were performed the palatal pedicle subepithelial connective tissue flap after the extraction, following the technique described by Khoury & Happe (2000), which consists of total detachment of the palatal flap followed by division of the flap to release the connective tissue, maintain a pedicle and sliding it to cover the fresh socket by primary intention. The sutures were removed seven to ten days of postoperative.

    On patients of this group were performed the palatal pedicle flap like the group 1, however, the sockets were previously filled with a graft of synthetic bone substitute (Bone Ceramic®, Straumann, Switzerland) and then recovered with the connective flap and sutured by primary intention. The sutures were removed seven to ten days of postoperative.

    On patients of this group, after the extraction of the tooth, were made a provisional ovoid pontic with acrylic resin or with the crown of the removed tooth itself, cut and sealed with composite resin. The pontics were placed to seal the entire gingival margin of the socket and penetrating 2 to 3 mm into it, stabilized laterally by the adjacent teeth with orthodontic and composite resin or acrylic resin. No sutures were made.

    Outcomes

    Primary Outcome Measures

    Changes of bone remodelation measured by Cone-Beam Computed Tomography exams and by plaster casts analysis, from baseline to 4 months
    Will be measured width and height buccal-lingual of the ridge for each tooth extracted by the researcher.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2017
    Last Updated
    May 23, 2017
    Sponsor
    Federal University of Juiz de Fora
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03166475
    Brief Title
    Ridge Preservation With Provisional Ovoid Pontic
    Official Title
    Ridge Preservation With Provisional Ovoid Pontic: a Randomized and Controlled Clinical-tomographic Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 30, 2016 (Actual)
    Primary Completion Date
    January 10, 2017 (Actual)
    Study Completion Date
    March 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Juiz de Fora

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alveolar Process Atrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Palatal pedicle flap (Group 1)
    Arm Type
    Experimental
    Arm Description
    On patients of this group were performed the palatal pedicle subepithelial connective tissue flap after the extraction, following the technique described by Khoury & Happe (2000), which consists of total detachment of the palatal flap followed by division of the flap to release the connective tissue, maintain a pedicle and sliding it to cover the fresh socket by primary intention. The sutures were removed seven to ten days of postoperative.
    Arm Title
    Graft + palatal pedicle flap (Group 2)
    Arm Type
    Experimental
    Arm Description
    On patients of this group were performed the palatal pedicle flap like the group 1, however, the sockets were previously filled with a graft of synthetic bone substitute (Bone Ceramic®, Straumann, Switzerland) and then recovered with the connective flap and sutured by primary intention. The sutures were removed seven to ten days of postoperative.
    Arm Title
    Provisional ovoid pontic (Group 3)
    Arm Type
    Experimental
    Arm Description
    On patients of this group, after the extraction of the tooth, were made a provisional ovoid pontic with acrylic resin or with the crown of the removed tooth itself, cut and sealed with composite resin. The pontics were placed to seal the entire gingival margin of the socket and penetrating 2 to 3 mm into it, stabilized laterally by the adjacent teeth with orthodontic and composite resin or acrylic resin. No sutures were made.
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical procedures
    Intervention Description
    All the extractions were performed under local anaesthesia, minimally traumatic as possible. After the extraction, each patient was treated according to the group of their allocations.
    Primary Outcome Measure Information:
    Title
    Changes of bone remodelation measured by Cone-Beam Computed Tomography exams and by plaster casts analysis, from baseline to 4 months
    Description
    Will be measured width and height buccal-lingual of the ridge for each tooth extracted by the researcher.
    Time Frame
    Baseline (immediate postoperative) and 4 months after it.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be shared with other researchers, the data will be used for the same researcher on other research later.
    Citations:
    PubMed Identifier
    21091540
    Citation
    Ten Heggeler JM, Slot DE, Van der Weijden GA. Effect of socket preservation therapies following tooth extraction in non-molar regions in humans: a systematic review. Clin Oral Implants Res. 2011 Aug;22(8):779-88. doi: 10.1111/j.1600-0501.2010.02064.x. Epub 2010 Nov 22.
    Results Reference
    result
    PubMed Identifier
    27712001
    Citation
    Iocca O, Farcomeni A, Pardinas Lopez S, Talib HS. Alveolar ridge preservation after tooth extraction: a Bayesian Network meta-analysis of grafting materials efficacy on prevention of bone height and width reduction. J Clin Periodontol. 2017 Jan;44(1):104-114. doi: 10.1111/jcpe.12633. Epub 2016 Dec 5.
    Results Reference
    result
    PubMed Identifier
    16515093
    Citation
    Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29.
    Results Reference
    result
    PubMed Identifier
    24621203
    Citation
    Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12.
    Results Reference
    result
    PubMed Identifier
    12956475
    Citation
    Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
    Results Reference
    result
    PubMed Identifier
    24600657
    Citation
    Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Relationship between the buccal bone plate thickness and the healing of postextraction sockets with/without ridge preservation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):211-7. doi: 10.11607/prd.1885.
    Results Reference
    result
    PubMed Identifier
    27335267
    Citation
    Nart J, Barallat L, Jimenez D, Mestres J, Gomez A, Carrasco MA, Violant D, Ruiz-Magaz V. Radiographic and histological evaluation of deproteinized bovine bone mineral vs. deproteinized bovine bone mineral with 10% collagen in ridge preservation. A randomized controlled clinical trial. Clin Oral Implants Res. 2017 Jul;28(7):840-848. doi: 10.1111/clr.12889. Epub 2016 Jun 22.
    Results Reference
    result
    PubMed Identifier
    23163915
    Citation
    Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
    Results Reference
    result
    PubMed Identifier
    10874807
    Citation
    Khoury F, Happe A. The palatal subepithelial connective tissue flap method for soft tissue management to cover maxillary defects: a clinical report. Int J Oral Maxillofac Implants. 2000 May-Jun;15(3):415-8.
    Results Reference
    result
    PubMed Identifier
    20636724
    Citation
    Mardas N, Chadha V, Donos N. Alveolar ridge preservation with guided bone regeneration and a synthetic bone substitute or a bovine-derived xenograft: a randomized, controlled clinical trial. Clin Oral Implants Res. 2010 Jul;21(7):688-98. doi: 10.1111/j.1600-0501.2010.01918.x.
    Results Reference
    result
    PubMed Identifier
    26660705
    Citation
    Ryu KH, Min S, You HK, Sin YW, Lee W, Lee J, Kiss A, Almohaimeed M, Zadeh HH. Alveolar ridge dimensional changes following ridge preservation procedure using SocketKAP() : exploratory study of serial cone-beam computed tomography and histologic analysis in canine model. Clin Oral Implants Res. 2016 Sep;27(9):1144-51. doi: 10.1111/clr.12711. Epub 2015 Dec 13.
    Results Reference
    result
    PubMed Identifier
    28402351
    Citation
    Fickl S, Fischer K, Petersen N, Happe A, Schlee M, Schlagenhauf U, Kebschull M. Dimensional Evaluation of Different Ridge Preservation Techniques: A Randomized Clinical Study. Int J Periodontics Restorative Dent. 2017 May/Jun;37(3):403-410. doi: 10.11607/prd.2629.
    Results Reference
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    Ridge Preservation With Provisional Ovoid Pontic

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