Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone

Soft Tissue Augmentation Using The Dome Technique Around Immediate Implants In The Esthetic Zone. A Case Series

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).

Study Overview

• Status: Unknown
• Conditions: Recession, Gingival
• Intervention / Treatment: Procedure: connective tissue grafting by Dome Technique

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Dome technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink esthetic score (PES)	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Thickness	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	6 months
Post - Surgical Patient Satisfaction	A 3 - item questionnaire is asked and the patients shall use a 7point answer scale	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Irinakis T, Aldahlawi S. The dome technique: a new surgical technique to enhance soft-tissue margins and emergence profiles around implants placed in the esthetic zone. Clin Cosmet Investig Dent. 2018 Feb 14;10:1-7. doi: 10.2147/CCIDE.S154152. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: CEBD-CU-2019-01-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No