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Effectiveness of the Papillary Extended Connective Tissue Graft in Miller Class III Gingival Recession

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
peCTG+CAF
CTG+CAF
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18 years or older. Periodontally and systemically healthy. Buccal recession defects classified as Miller class III. Presence of identifiable CEJ (Zucchelli et al., 2010). Clinical indication and/or patient demand for recession coverage. O'Leary index less than 20% (O'Leary et al., 1972).

Exclusion Criteria:

  • Miller class I, II or IV recession defects. Pregnant females. Smokers as smoking is contraindicated at any plastic periodontal surgery (Khuller, 2009).

Handicapped and mentally retarded patients. Teeth with cervical restorations or abrasion. Taking medication known to affect periodontal healing. Previous periodontal surgery on the involved site.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    CTG+CAF

    peCTG+CAF

    Arm Description

    The surgical procedure will include a connective tissue graft harvested from the palate and used under a coronally advanced flap

    A papillary extended connective tissue graft reshaped after harvested from the palate will be used under a coronally advanced flap

    Outcomes

    Primary Outcome Measures

    Recession Depth in mm
    The vertical amount of root exposed will be measured using a UNC-15 periodontal probe

    Secondary Outcome Measures

    Recession Width in mm
    The width of the exposed root will be measured using a UNC-15 periodontal probe
    Probing depth in mm
    Measured from the gingival margin to the base of the sulcus will be measured using a UNC-15 periodontal probe
    Gingival thickness in mm
    the thickness of the gingival tissues will be measured by piercing the gingiva till touching bone with a #15 endodontic reamer under anethesia
    Width of keratinized gingiva in mm
    from the gingival margin to the mucogingival junction will be measured using a UNC-15 periodontal probe
    Root coverage esthetic score (Cairo et al. 2009)
    evaluation of the esthetic outcomes of root coverage procedures according to Cairo et al. 2009 Root Coverage Esthetic Score
    Patient satisfaction (Kim et al. 2014)
    measuring the degree of satisfaction of the patients according to Kim et al. 2014 questionnaire

    Full Information

    First Posted
    January 18, 2018
    Last Updated
    January 24, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03416673
    Brief Title
    Effectiveness of the Papillary Extended Connective Tissue Graft in Miller Class III Gingival Recession
    Official Title
    Clinical Effectiveness of Coronally Advanced Flap With Papillary Extended Connective Tissue Graft Versus Connective Tissue Graft in Miller Class III Recession: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2018 (Anticipated)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    February 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    Brief Summary
    34 patients with Miller class III will be included in this study, where 17 participants will be treated with connective tissue graft with coronally advanced flap (control group) and 17 participants will be treated with a papillary extended connective tissue graft with coronally advanced flap (test group) and followed up for 6 months.
    Detailed Description
    Each patient will be inspected to check if the patient fits for the eligibility criteria. If the patient meets the standards, phase I therapy for periodontal plastic procedures will be performed including thorough supragingival scaling and subgingival debridement. Preservation of appropriate plaque control (both mechanical and chemical) by the patient will be executed as well. Surgical procedures: It will be done by the principal investigator. CTG harvesting: A measurement of the approximate length and width of the graft required will be taken. A CTG will be harvested from the palate using single incision technique as described by Kumar et al. (2013) as follows: The graft will be harvested from the palate between the distal aspect of the canine and the mid-palatal region of the first molar. A template will be placed on the palate to mark the extent of the graft, after local anesthesia is administered. A single incision 2 mm apical to the gingival margin will be done. The blade will be placed approximately parallel to the long axis of the palate to provide the first incision. The partial thickness flap will be raised as far apically as required, in accordance with the graft size, as measured by the template, using a periosteal elevator. The thickness of the flap will be sufficient to reduce the probability of tearing and sloughing. Following this, the blade will be angled perpendicular to the palate through the same incision and continued to the bone. After the incision to the bone, the connective tissue will be elevated from the underlying bone with a periosteal elevator. Then two vertical incisions on the mesial and distal ends of the graft and one horizontal medial incision will be performed (under the partial thickness flap), to release it from the surrounding tissue. The graft will be harvested through that single incision and pressure applied to the donor site with gauze soaked in saline after the graft was taken. The donor site will be sutured using a 4-0 silk suture. For the peCTG, the CTG will be furtherly prepared by creating the papillary extensions using a tissue punch, according to the number of teeth with gingival recession. Surgical protocol: The surgical area will be prepared and adequately anesthetized using 4% articaine hydrochloride 1/100 000 epinephrine by giving block and/or infiltration anesthesia. After attaining adequate anesthesia, at a point apical to the papilla tip, vertical incisions will be made lateral to the area of recession extending into alveolar mucosa. The alveolar mucosa between the two vertical incisions will then be undermined by sharp dissection with undermining going into the vestibule while remaining parallel with the surface. Then, a sulcular incision will be used to reflect the coronal portion of the flap by sharp dissection close to the periostium until reaching the split thickness incision previously made in alveolar mucosa. A gingivoplasty of each papilla adjacent to the recession will then be performed. This excision will not reduce the height of the papilla, but is designed to create a bleeding surface which will serve as a bed for the connective tissue graft (Allen and Miller, 1989). A triangular flap will be elevated by a sharp dissection with no. 15c scalpel blade to raise a combined full-partial thickness flap to the level of the MGJ. In the test group (group A), peCTG will be placed over the recession defect leaving the coronal margin of the graft at the level of the CEJ, and the papillary extensions are inserted interdentally covering the de-epithelized papillae, while in the control group (group B), CTG will be also placed over the recession defect leaving the coronal margin of the graft at the level of the CEJ. In both groups, all graft material will be sutured to the periosteum using 6-0 resorbable suture. Finally the flaps will be positioned coronally to the CEJ without tension using 6-0 polyglycolic acid suture material. Hemostasis will be achieved by applying gentle finger pressure for 4 minutes. Post-surgical protocol: Postoperative oral analgesics (Ibuprofen 600 mg t.d.s) will be prescribed to the patients for the first 3 days then whenever desirable. Systemic antibiotic will be prescribed (Amoxicillin 500mg t.d.s) for 5 days to prevent the infection postsurgical. Patients will be instructed to rinse with 0.12% Chlorhexidine oral rinse twice daily for 2 weeks. Participants will be instructed to avoid excessive muscle tractioning or trauma to the treated areas for the first 3 weeks and will be told not to brush teeth involved in the surgery. After 10-14 days the sutures will be removed. Three weeks post surgically the patients will be instructed to gently brush the operated area with a soft tooth brush using roll technique.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CTG+CAF
    Arm Type
    Active Comparator
    Arm Description
    The surgical procedure will include a connective tissue graft harvested from the palate and used under a coronally advanced flap
    Arm Title
    peCTG+CAF
    Arm Type
    Experimental
    Arm Description
    A papillary extended connective tissue graft reshaped after harvested from the palate will be used under a coronally advanced flap
    Intervention Type
    Procedure
    Intervention Name(s)
    peCTG+CAF
    Intervention Description
    A connective tissue graft will be reshaped to have extensions mimicking the papillae to augment the inter-dental papillae recessed
    Intervention Type
    Procedure
    Intervention Name(s)
    CTG+CAF
    Intervention Description
    A connective tissue graft harvested from the palate will be sutured to the gingival recession site and covered with a coronally advanced flap
    Primary Outcome Measure Information:
    Title
    Recession Depth in mm
    Description
    The vertical amount of root exposed will be measured using a UNC-15 periodontal probe
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Recession Width in mm
    Description
    The width of the exposed root will be measured using a UNC-15 periodontal probe
    Time Frame
    6 months
    Title
    Probing depth in mm
    Description
    Measured from the gingival margin to the base of the sulcus will be measured using a UNC-15 periodontal probe
    Time Frame
    6 months
    Title
    Gingival thickness in mm
    Description
    the thickness of the gingival tissues will be measured by piercing the gingiva till touching bone with a #15 endodontic reamer under anethesia
    Time Frame
    6 months
    Title
    Width of keratinized gingiva in mm
    Description
    from the gingival margin to the mucogingival junction will be measured using a UNC-15 periodontal probe
    Time Frame
    6 months
    Title
    Root coverage esthetic score (Cairo et al. 2009)
    Description
    evaluation of the esthetic outcomes of root coverage procedures according to Cairo et al. 2009 Root Coverage Esthetic Score
    Time Frame
    6 months
    Title
    Patient satisfaction (Kim et al. 2014)
    Description
    measuring the degree of satisfaction of the patients according to Kim et al. 2014 questionnaire
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18 years or older. Periodontally and systemically healthy. Buccal recession defects classified as Miller class III. Presence of identifiable CEJ (Zucchelli et al., 2010). Clinical indication and/or patient demand for recession coverage. O'Leary index less than 20% (O'Leary et al., 1972). Exclusion Criteria: Miller class I, II or IV recession defects. Pregnant females. Smokers as smoking is contraindicated at any plastic periodontal surgery (Khuller, 2009). Handicapped and mentally retarded patients. Teeth with cervical restorations or abrasion. Taking medication known to affect periodontal healing. Previous periodontal surgery on the involved site.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Manar T Elzanaty, Master
    Phone
    +201001775660
    Email
    manar.elzanaty@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Noha A Ghallab, Doctorate
    Phone
    +201005263365
    Email
    noha.ghallab@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manar T Elzanaty, Master
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    22639845
    Citation
    Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28.
    Results Reference
    background
    PubMed Identifier
    25644302
    Citation
    Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
    Results Reference
    background
    PubMed Identifier
    24174767
    Citation
    Kumar A, Sood V, Masamatti SS, Triveni MG, Mehta DS, Khatri M, Agarwal V. Modified single incision technique to harvest subepithelial connective tissue graft. J Indian Soc Periodontol. 2013 Sep;17(5):676-80. doi: 10.4103/0972-124X.119294.
    Results Reference
    background
    PubMed Identifier
    19335093
    Citation
    Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
    Results Reference
    background

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    Effectiveness of the Papillary Extended Connective Tissue Graft in Miller Class III Gingival Recession

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