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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05776498
Enrollment
30
Registered
2023-03-20
Start date
2021-06-01
Completion date
2023-08-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Dental Implants

Keywords

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

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?

Interventions

PROCEDUREimmediate 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.

PROCEDUREimmediate 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pink esthetic score (PES)3 months after crown placementTo evaluate the pink esthetic score 1-14 score

Secondary

MeasureTime frameDescription
Mid-facial recession1 year3D viewer soft tissue
Interdental papilla1 year3D viewer soft tissue
Volumetric analysis of buccal contour6 months3D 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
Bone formed labial to the implant1 yearCBCT cone beam CT
gingival biotype1 yearthickness in millimeters mm
Horizontal labio-palatal bone width1 yearCBCT cone beam CT

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026