Peri-implant Tissue Changes Using Dual Zone Concept with Connective Tissue Graft Versus Concentrated Growth Factor
NCT06728696 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2025-02-17
Summary
Tooth extraction not only alters the bony architecture of the alveolar ridge, but it also has an impact on the surrounding soft tissues. Post-extraction recovery of both hard and soft tissues occurs uneventfully, resulting in horizontal and vertical tissue loss, affecting prosthetic rehabilitation with dental implants or tooth-supported prosthesis.
Aim of the study:
The aim of this study is to evaluate volumetric soft tissue alterations as well as clinical, radiographic, and esthetic outcomes in dual zone technique (DZ) using CTG (Connective Tissue Graft) versus CGF (Concentrated Growth Factor) Graft following maxillary IIP (Immediate Implant Placement) in the esthetic zone.
Materials and methods:
20 patients with hopeless teeth requiring extraction in maxillary esthetic zone and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, Ain Shams University according to the inclusion criteria. They will be randomly allocated into two equal groups. Group I (n=17) immediate implant placement with dual zone technique using concentrated growth factor graft and group II (n=17) immediate implant placement with dual zone technique using connective tissue graft. Pink esthetic score (PES) was measured 6 months after the final crown placement. At the respective times radiographic CBCT measurements, volumetric analysis, and clinical measurements will be taken. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed. Data collected will be tabulated and statistically analyzed.
Conditions
- Hopeless Tooth in Esthetic Zone
- Loss of Soft and Hard Tissue Around Implant
- Immediate Implant Placement
Interventions
- PROCEDURE
-
Immediate implant with with dual zone technique using concentrated growth factor graft.
In the test group, pouch technique + CGFG will be used. The CGFG will be packed in the split-thickness labial pouch between the labial bone plate and the overlying gingiva of the extraction socket. A convenient blood sample will be withdrawn from a peripheral venous blood from the patient using a specialized vacutaine. A standard, disposable, 10-ml non- anticoagulant tube and a matching centrifuge device was used. To prepare the CGFG, the centrifuge is accelerated for 30 seconds, then centrifuged at 2700 rpm for 2 minutes, 2400 rpm for 4 minutes, 2700 rpm for 4 minutes, and 3000 rpm for 3 minutes before being decelerated for 36 seconds to stop.
- PROCEDURE
-
Immediate implant with dual zone technique using connective tissue graft.
Patients assigned to the control group will receive pouch technique + CTG. Following implant placement, a split-thickness labial pouch between the labial bone plate and the overlying gingiva of the extraction socket will be performed using 15c mini blade to allow for the placement of a CTG. The pouch preparation will be extended apical beyond the muco-gingival junction and to the neighboring teeth mesiodistally. The CTG will be harvested from the palate with a thickness of 1.5 mm using single-incision technique, which was done approximately 2-3 mm apical to the gingival margin of the maxillary teeth and parallel to the palatal long axis. A resorbable suture will be used to first pierce the labial mucosa along with the periosteum at an apical part, which then exits from the sulcus. Afterward, the CTG will be tucked in the pouch, labial to the suture, and held at a coronal area by using the needle to pierce it from its inner surface toward the labial soft tissue. The knot will then be se
Sponsors & Collaborators
-
Ain Shams University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-01-15
- Primary Completion
- 2025-03-15
- Completion
- 2025-06-15
Countries
- Egypt
Study Locations
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