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Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03802370
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : January 16, 2019
Information provided by (Responsible Party):
Yasmine Abbas Elsayed, Cairo University

Brief Summary:
Following tooth loss, a considerable reduction in hard- and soft-tissue volume can be expected (Tan WL, et al., 2012), (AraujoMG, et al., 2015). In the anterior maxilla, tissue loss can make future implant restorations more challenging and less predictable in terms of achieving and maintaining favorable soft-tissue-emergence profiles. Even with careful implant planning and placement, marginal gingival recession of 0.5-1 mm has been a common finding with single-tooth implants (Nisapakultorn K, et al., 2010), (Suphanantachat S, et al., 2012). This is partly attributed to bone remodeling after implant surgery, and occurs regardless of implant-placement protocol used (Hof M, et al., 2015).

Condition or disease Intervention/treatment Phase
Recession, Gingival Procedure: connective tissue grafting by Dome Technique Not Applicable

Detailed Description:
The dome technique addresses the placement of the CT, as it is layered over the implant and takes the shape of an inverted dome. The advantage of the dome CT technique is that it allows for both buccal and coronal augmentation of local soft tissue, while maximizing blood supply to the area by using tunneling-technique principles. It enhances and augments the peri-implant tissue foundation for a favorable facial and interproximal restorative emergence profile. As this technique does not involve raising an independent buccal flap, the gingival tissue of the adjacent teeth is not compromised, and thus the risk of recession and formation of black triangles on the adjacent teeth is minimized.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single arm groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Soft Tissue Augmentation Using The Dome Technique Around Immediate Implants In The Esthetic Zone. A Case Series
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : February 1, 2020

Arm Intervention/treatment
single am
single arm , superiority trial , tunneling technique in connective tissue graft around dental implants
Procedure: connective tissue grafting by Dome Technique
The dome technique addresses the placement of the CT, as it is layered over the implant and takes the shape of an inverted dome
Other Name: Dome technique

Primary Outcome Measures :
  1. Pink esthetic score (PES) [ Time Frame: 6 months ]
    The PES is based on seven variables mesial papilla, distal papilla, soft - tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture . The PES is based on seven variables mesial papilla, distal papilla, soft - tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture . it's numerical

Secondary Outcome Measures :
  1. Gingival Thickness [ Time Frame: 6 months ]
    Will be measured using an anesthetic needle with a rubber stopper, trans-gingivally piercing tissues horizontally perpendicular to the long axis of the tooth implant until it contacts bone

  2. Post - Surgical Patient Satisfaction [ Time Frame: 6 months ]
    A 3 - item questionnaire is asked and the patients shall use a 7point answer scale

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with healthy systemic condition
  • Patients aged from 20 to 45 years old Availability of bone apical and palatal to the socket to provide primary stability.
  • Presence of adequate gingival architecture with the surrounding dentition
  • Patient provides an informed consent
  • Adequate Inter-arch space for implant placement
  • Favorable occlusion (no traumatic occlusion)
  • Good oral hygiene
  • Accepts 6-month follow-up period

Exclusion Criteria:

  • Patients with signs of acute infection related to the area of interest
  • Patients with habits that may jeopardize the implant longevity and affect the results of the study such as para-functional habits
  • Current and former smokers
  • Pregnant females
  • HIV or Hepatitis; 5/Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Alcoholism or chronic drug abuse; 7/ Heavy smokers >10/cigarettes per day
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Responsible Party: Yasmine Abbas Elsayed, professor: Mona Shoeib , associated professor: Enji ahmed mahmoud, Cairo University Identifier: NCT03802370    
Other Study ID Numbers: CEBD-CU-2019-01-10
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy