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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 34
- Primary Endpoint
- Volumetric Analysis of Mid-facial recession
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patient-related criteria:
- •Adults at or above the age of
- •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
Arms & Interventions
Immediate implant & Connective tissue graft
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 supra-periosteal 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.
Intervention: Immediate implant and connective tissue graft (Procedure)
Immediate implant with connective tissue graft & bone graft
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 supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will be used to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.
Intervention: Immediate implant with connective tissue graft and bone graft (Procedure)
Outcomes
Primary Outcomes
Volumetric Analysis of Mid-facial recession
Time Frame: Preoperative,3months,6months and 12 months
3d viewer will be used to the the midfacial recession .
Secondary Outcomes
- Volumetric analysis of Interdental papillae height(Preoperative , 3 months, 6 months and 12 months)
- Bone formed labial to the implant(Preoperative and 1 year)
- Horizontal labio-palatal bone collapse((Preoperative and 1 year))
- Vertical crestal bone level changes(Preoperative and 1 year)
- Gingival biotype(Preoperative, 6 months and 12 months)
- Volumetric analysis of buccal contour(Preoperative,3months,6months and 12 months)
- Full mouth bleeding score (FMBS)(Preoperative, 6months and 12 months)
- Pain and discomfort(At 1,3 and 7 days after the surgery)
- Full mouth plaque score (FMPS)(Preoperative, 6 months and 12 months)
- Pink Esthetic Score(at 12 months)
- Horizontal labio-palatal bone collapse(Preoperative and 1 year)
Investigators
Norai Ahmed Mohamed Zayed
Assistant Lecturer
Cairo University