Clinical trial NCT03802370: Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone
Official title: Soft Tissue Augmentation Using The Dome Technique Around Immediate Implants In The Esthetic Zone. A Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recession, Gingival
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm groups
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pink esthetic score (PES)
timeFrame: 6 months
Secondary outcomes:
measure: Gingival Thickness
timeFrame: 6 months
measure: Post - Surgical Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.