Peri-implant Tissue Changes Using Dual Zone Concept with Connective Tissue Graft Versus Concentrated Growth Factor

NCT06728696 | Enrolling By Invitation DMC

• 1 other identifier: 1383
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Immediate implant; Esthetic zone; Connective Tissue Graft; Concentrated Growth Factor Graft

Outcome Measures

Primary Outcomes (1)

• Volumetric analysis

  3D viewer soft tissue; mm changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin

  Baseline and 6 months

Secondary Outcomes (5)

• Pink Esthetic Score

  6 months after final crown placement

• Radiographic CBCT measurements

  Baseline and 6 months

• Full-mouth plaque score

  Baseline and 6 months

• Full-mouth bleeding score

  Baseline and 6 months

• Visual Analog Scale

  1, 3, and 7 days after the surgery.

Study Arms (2)

Group I (Test group):

EXPERIMENTAL

17 patients with non-restorable tooth in the esthetic zone will receive atraumatic extraction followed by immediate implant placement with dual zone technique using concentrated growth factor graft.

Procedure: Immediate implant with with dual zone technique using concentrated growth factor graft.

Group II (Control group):

ACTIVE COMPARATOR

17 patients with non-restorable tooth in the esthetic zone will receive atraumatic extraction followed by immediate implant placement with dual zone technique using connective tissue graft.

Procedure: Immediate implant with dual zone technique using connective tissue graft.

Interventions

Immediate implant with with dual zone technique using concentrated growth factor graft. PROCEDURE

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.

Group I (Test group):

Immediate implant with dual zone technique using connective tissue graft. PROCEDURE

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

Group II (Control group):

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically (medically) free individuals were recruited for the present study according to the modified Burkett's health history questionnaire, ASA.
• Males and females with age range 20 - 50.
• Patients having a history of hopeless tooth in esthetic zone (Anteriors/Premolars) indicated for extraction and immediate implant placement.
• Patients who are cooperative and maintain proper oral hygiene.
• Intact interproximal and palatal bone extending at least 6 mm apically, with sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque).

You may not qualify if:

• Heavy smokers. 20
• Patients who exhibit parafunctional occlusal habits 21
• Pregnant ladies or lactating mothers.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to the type of the intervention and the whole-time frame of the study will be 6 months.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel design, two arms clinical trial.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 11, 2024
• Study Start: January 15, 2025
• Primary Completion: March 15, 2025
• Study Completion: June 15, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-09

Locations

EG (1)