Clinical trial NCT05776498: Evaluation of Immediate Implant Placement Using Dual Zone Approach Versus Connective Tissue Graft
Official title: Clinical and Radiographic Evaluation of Immediate Implant Placement Using Dual Zone Approach Versus Connective Tissue Graft: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immediate Dental Implants
Keywords: Immediate dental implants
anterior maxilla
esthetic zone
connective tissue graft
dual zone technique
bone graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


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

Primary outcomes:
measure: pink esthetic score (PES)
timeFrame: 3 months after crown placement
Secondary outcomes:
measure: Volumetric analysis of buccal contour
timeFrame: 6 months
measure: Mid-facial recession
timeFrame: 1 year
measure: Interdental papilla
timeFrame: 1 year
measure: Horizontal labio-palatal bone width
timeFrame: 1 year
measure: Bone formed labial to the implant
timeFrame: 1 year
measure: gingival biotype
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: International Dental Continuing Education
Study officials:
affiliation: Professor of Oral Medicine & Periodontology
name: Noha A Ghallab, PhD
role: STUDY_DIRECTOR
References: