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

NCT05776498 | Unknown

• 1 other identifier: IDCE.N3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Immediate dental implants; anterior maxilla; esthetic zone; connective tissue graft; dual zone technique; bone graft

Outcome Measures

Primary Outcomes (1)

• pink esthetic score (PES)

  To evaluate the pink esthetic score 1-14 score

  3 months after crown placement

Secondary Outcomes (6)

• Volumetric analysis of buccal contour

  6 months

• Mid-facial recession

  1 year

• Interdental papilla

  1 year

• Horizontal labio-palatal bone width

  1 year

• Bone formed labial to the implant

  1 year

Study Arms (2)

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

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.

immediate implant placement with connective tissue grafting

EXPERIMENTAL

immediate implant placement with connective tissue grafting

Procedure: immediate implant placement with connective tissue grafting

Interventions

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

immediate implant placement with connective tissue grafting 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.

immediate implant placement with connective tissue grafting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

International Dental Continuing Education

Cairo, 00000, Egypt

Location

Study Officials

• Noha A Ghallab, PhD

  Professor of Oral Medicine & Periodontology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in the department of Oral Medicine & Periodontology

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: June 1, 2021
• Primary Completion: May 15, 2023
• Study Completion: August 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

EG (1)