Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone

NCT03802370 | Unknown DMC

• 1 other identifier: CEBD-CU-2019-01-10
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Recession, Gingival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gingival Thickness

  6 months

• Post - Surgical Patient Satisfaction

  6 months

Study Arms (1)

single am

OTHER

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

Procedure: connective tissue grafting by Dome Technique

Interventions

connective tissue grafting by Dome Technique 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

Also known as: Dome technique

single am

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 29491722 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor: Mona Shoeib , associated professor: Enji ahmed mahmoud

Model Details: single arm groups

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: February 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: February 1, 2020
• Last Updated: January 16, 2019

Record last verified: 2019-01