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

NCT ID: NCT05776498

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-08-31

Brief Summary

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?

Conditions

Immediate Dental Implants

Study Design

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

Study Groups

immediate implant placement with particulate bone graft using the dual zone technique.

immediate implant placement with particulate bone graft using the dual zone technique.

Group Type: EXPERIMENTAL

immediate implant placement with particulate bone graft using the dual zone technique.

Intervention Type: PROCEDURE

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.

immediate implant placement with connective tissue grafting

immediate implant placement with connective tissue grafting

Group Type: EXPERIMENTAL

immediate implant placement with connective tissue grafting

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Mohamed Fouad Shemais

Lecturer in the department of Oral Medicine & Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha A Ghallab, PhD

Role: STUDY_DIRECTOR

Professor of Oral Medicine & Periodontology

Locations

International Dental Continuing Education

Cairo, , Egypt

Countries

Egypt

Other Identifiers

IDCE.N3

Identifier Type: -

Identifier Source: org_study_id