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
Connective tissue graft /Bone graft/ Customized HA
Prevention Study
Summary
Study start date: January 13, 2022
Actual date on which the first participant was enrolled.The study focuses on improving the appearance and stability of the gums after a tooth is extracted and an implant is placed. When a tooth is removed, the surrounding gum and bone can change shape, causing the gum line to recede. This research aims to find out if using special devices called customized contoured healing abutments, along with or without connective tissue grafts, can better maintain the original appearance and shape of the gums. This is important because it seeks to provide a solution that not only enhances the look but also ensures the long-term stability of the gums and surrounding tissues, especially in visible areas of the mouth. Participants in the study receive immediate implants after tooth extraction in the front part of the mouth, known as the esthetic zone. They are then treated with either a customized healing abutment or a combination of the abutment and connective tissue graft. The study observes how well these methods maintain the gum's shape and position over a year. The results are evaluated by looking at the gum line changes and overall tissue stability, helping determine the most effective technique for preserving the natural appearance of gums after dental implants.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.39 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location