Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone

Recession, Gingival Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03802370
• Other study ID #: CEBD-CU-2019-01-10
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Recession, Gingival

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Post - Surgical Patient Satisfaction	A 3 - item questionnaire is asked and the patients shall use a 7point answer scale	6 months