Clinical trial NCT05975515: Midfacial Gingival Margin Changes Following Immediate Implants.
Official title: Effect of Soft Tissue Volume on Midfacial Gingival Margin Alterations Following Immediate Implant Placement in the Esthetic Zone: A 1-Year Randomized Clinical and Volumetric Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial, parallel groups, three-arm, superiority trial with 1:1:1 allocation ratio.
Primary purpose: PREVENTION

Brief summary: Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics

Detailed description: 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).

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.
  * Good oral hygiene.
  * 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: Midfacial Gingival Margin Changes
timeFrame: 12 months
Secondary outcomes:
measure: Bone labial to the implant
timeFrame: 12 months
measure: Volumetric analysis of buccal contour&Total Volume
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: IDCE
Study officials:
References: