Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone

NCT ID: NCT03802370

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-02-01

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).

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.

Conditions

Recession, Gingival

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single am

single arm , superiority trial , tunneling technique in connective tissue graft around dental implants

Group Type: OTHER

connective tissue grafting by Dome Technique

Intervention Type: PROCEDURE

The dome technique addresses the placement of the CT, as it is layered over the implant and takes the shape of an inverted dome

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Dome technique

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmine Abbas Elsayed

professor: Mona Shoeib , associated professor: Enji ahmed mahmoud

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 29491722 (View on PubMed)

Other Identifiers

CEBD-CU-2019-01-10

Identifier Type: -

Identifier Source: org_study_id