Back to results

Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone

Primary Purpose

Recession, Gingival

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

connective tissue grafting by Dome Technique

About this trial

This is an interventional treatment trial for Recession, Gingival

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single am

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Post - Surgical Patient Satisfaction

A 3 - item questionnaire is asked and the patients shall use a 7point answer scale

Full Information

NCT ID

NCT03802370

First Posted

January 10, 2019

Last Updated

January 14, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03802370

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2019 (Anticipated)

Primary Completion Date

October 1, 2019 (Anticipated)

Study Completion Date

February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recession, Gingival

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

single arm groups

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single am

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

connective tissue grafting by Dome Technique

Other Intervention Name(s)

Dome technique

Intervention 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

Primary Outcome Measure Information:

Title

Pink esthetic score (PES)

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Gingival Thickness

Description

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

Time Frame

6 months

Title

Post - Surgical Patient Satisfaction

Description

A 3 - item questionnaire is asked and the patients shall use a 7point answer scale

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29491722

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.

Results Reference

background

Learn more about this trial

Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone

We'll reach out to this number within 24 hrs