Clinical trial NCT06592079: Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone
Official title: Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Immediate Implants Connective Tissue Graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group.

Detailed description: This randomized clinical trial will evaluate the effect of using connective tissue graft and bone graft versus connective tissue graft, with customized healing abutments during immediate implant placement on volumetric mid facial recession .In patients with type I socket who need extraction in the anterior maxilla.

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: Volumetric Analysis of Mid-facial recession
timeFrame: Preoperative,3months,6months and 12 months
Secondary outcomes:
measure: Volumetric analysis of Interdental papillae height
timeFrame: Preoperative , 3 months, 6 months and 12 months
measure: Bone formed labial to the implant
timeFrame: Preoperative and 1 year
measure: Horizontal labio-palatal bone collapse
timeFrame: Preoperative and 1 year
measure: Vertical crestal bone level changes
timeFrame: Preoperative and 1 year
measure: Gingival biotype
timeFrame: Preoperative, 6 months and 12 months
measure: Volumetric analysis of buccal contour
timeFrame: Preoperative,3months,6months and 12 months
measure: Horizontal labio-palatal bone collapse
timeFrame: (Preoperative and 1 year)
measure: Full mouth bleeding score (FMBS)
timeFrame: Preoperative, 6months and 12 months
measure: Pain and discomfort
timeFrame: At 1,3 and 7 days after the surgery
measure: Full mouth plaque score (FMPS)
timeFrame: Preoperative, 6 months and 12 months
measure: Pink Esthetic Score
timeFrame: at 12 months
Other outcomes:
Locations:
Study officials:
References: