Evaluation of Immediate Implant Placement Using Dual Zone Approach Versus Connective Tissue Graft

Clinical and Radiographic Evaluation of Immediate Implant Placement Using Dual Zone Approach Versus Connective Tissue Graft: A Randomized Clinical Trial

Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019). In patients with non-restorable teeth in the esthetic zone, will the use of bone grafts to the dual zone with customized healing abutment vs the use of connective tissue graft with customized healing abutment in immediately placed implants shows better buccal contour avoiding horizontal collapse?

Study Overview

• Status: Active, not recruiting
• Conditions: Immediate Dental Implants
• Intervention / Treatment: Procedure: immediate implant placement with particulate bone graft using the dual zone technique.; Procedure: immediate implant placement with connective tissue grafting

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 00000
    • International Dental Continuing Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

Patient-related criteria:

• Adults at or above the age of 18.
• Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
• The failing tooth will have adjacent and opposing natural teeth.
• Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
• Able to tolerate surgical periodontal procedures.
• Full mouth plaque and bleeding scores less than 20%.
• Compliance with the maintenance program.
• Provide informed consent.
• Accepts the one-year follow-up period.

Teeth related criteria:

• Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
• Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
• Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm.

Exclusion criteria:

• Patients diagnosed with periodontal diseases.
• Current or previous smokers.
• Pregnant and lactating females.
• Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
• Patients with active infection related at the site of implant/bone graft placement.
• Patients with parafunctional habits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immediate implant placement with particulate bone graft using the dual zone technique.	Procedure: immediate implant placement with particulate bone graft using the dual zone technique.; Tooth extraction and immediate implant placement as mentioned, then particulate bone graft will be packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), then will be covered by a customized healing abutment.
Experimental: immediate implant placement with connective tissue grafting	Procedure: immediate implant placement with connective tissue grafting; Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pink esthetic score (PES)	To evaluate the pink esthetic score 1-14 score	3 months after crown placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric analysis of buccal contour	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	6 months
Mid-facial recession	3D viewer soft tissue	1 year
Interdental papilla	3D viewer soft tissue	1 year
Horizontal labio-palatal bone width	CBCT cone beam CT	1 year
Bone formed labial to the implant	CBCT cone beam CT	1 year
gingival biotype	thickness in millimeters mm	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Noha A Ghallab, PhD, Professor of Oral Medicine & Periodontology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): May 15, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: bone graft; connective tissue graft; esthetic zone; Immediate dental implants; anterior maxilla; dual zone technique
• Other Study ID Numbers: IDCE.N3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No