Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implant Using Dual Zone Therapeutic Concept Versus Buccal Gap Fill to Bone Level

NCT ID: NCT03768297

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2020-11-20

Brief Summary

Immediate implant placement in the esthetic zone is very challenging procedure although it is documented as a promising procedure (Berglundh, Persson and Klinge, 2002)(Cosyn et al., 2011). Extraction is usually accompanied by remodeling of the hard tissues which is more crucial in the anterior maxilla as it affects soft tissue esthetics(Araujo and Lindhe, 2005)(Covani et al., 2004)(Juodzbalys and Wang, 2007). It is well established that implant placement without filling the buccal gap leads to noticeable amount of bone loss at the alveolar contour(Botticelli, Berglundh and Lindhe, 2004)(Sanz et al., 2010). The protocol of immediate implant and temporization serves to provide acceptable esthetic results but soft tissue stability around the implant restoration is not always satisfactory(Noelken et al., 2018).Amount of soft tissue recession can be specified following immediate implant placement, even with flapless technique there is a limited risk of midfacial recession(Cosyn, Hooghe and De Bruyn, 2012).It was found that inadequate bone grafting in the facial defect increases the chance of mid facial recession(Le, Borzabadi-Farahani and Pluemsakunthai, 2014).

Detailed Description

By definition, the dual zone can be divided into soft tissue zone and bone zone; the soft tissue zone is the vertical dimension change measured from the free gingival margin to the mid crest labially, the bone zone is the hard tissues measured from the crestal bone towards the apex(Chu et al., 2012). The concept of the dual zone aims to maintain the hard, soft tissue volume and the blood clot where the grafting material act as a scaffold containing them and this will enhance the initial healing compared to the classic protocol of bone filling till the buccal bone level(Chu et al., 2012). A recent study claims that the xenograft particles can be successfully incorporated within the soft tissue without inflammation enhancing the soft tissue profile(Araujo and Lindhe, 2005). The temporary restoration has shown socket sealing property which protect and contain the blood clot and the graft material enhancing healing,thus filling the gap without involvement of the soft tissue has been the rational for immediate implant placement(Trimpou G, Weigl P, Krebs M, 2010).The main benefit of the dual zone concept is maintaining the blood supply from the periosteum and endosteum producing maximum healing potential with preserving the soft tissue stability by filling the soft tissue zone with bone graft in addition to immediate temporization acting as socket seal(Chu et al., 2012).

Conditions

Immediate Implant and Bone Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

immediate implant with dual zone therapeutic concept

Group Type: EXPERIMENTAL

dual zone concept

Intervention Type: PROCEDURE

immediate implant with bone fill till soft tissue level

immediate implant with buccal bone fill

Group Type: ACTIVE_COMPARATOR

dual zone concept

Intervention Type: PROCEDURE

immediate implant with bone fill till soft tissue level

Interventions

dual zone concept

immediate implant with bone fill till soft tissue level

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients who have at least one non restorable tooth in the esthetic zone that needs to be extracted.

2. Patients with healthy systemic condition.(Brightman. 1994)

3. Patients aged from 20 to 45 years old.

4. Buccal bone thickness should be at least 1mm. (Morton et al., 2014)

5. Availability of bone apical and palatal to the socket to provide primary stability.(Morton et al., 2014)

6. Good oral hygiene.(Wiesner et al., 2010)

7. Accepts one year follow-up period (cooperative patients).

8. Patient provides an informed consent.

9. Adequate Inter-arch space for implant placement.

10. favorable occlusion (no traumatic occlusion)

Exclusion Criteria

1. Patients with signs of acute infection related to the area of interest.

2. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).

3. Current and former smokers (Lambert, Morris and Ochi, 2000)

4. Pregnant females.

• 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

RWGWanis

Clinical Evaluation of soft tissue esthetics around immediate implant using dual zone therapeutic concept versus buccal gap fill to bone level

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2508

Identifier Type: -

Identifier Source: org_study_id