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

Cairo University0 sites34 target enrollmentNovember 4, 2024

ConditionsImmediate Implants Connective Tissue Graft

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Immediate Implants Connective Tissue Graft
Sponsor: Cairo University
Enrollment: 34
Primary Endpoint: Volumetric Analysis of Mid-facial recession
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 4, 2024

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cairo University

Responsible Party

Principal Investigator

Norai Ahmed Mohamed Zayed

Assistant Lecturer

Cairo University

Eligibility Criteria

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.

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

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)