Effectiveness of Hard Tissue Augmentation With or Without Connective Tissue Graft Following Immediate Dental Implants in the Esthetic Zone: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Baghdad
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Pink Esthetic Score (PES)
Study Overview
Brief Summary
This randomized controlled study is aimed to evaluate the esthetic, clinical, and radiographic outcomes following the placement of immediate single-tooth implant with hard and soft tissue augmentation.
Subjects will randomly assigned to one of two groups:
- Group A (control group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation only.
- Group B (study group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation and connective tissue graft (CTG).
The main questions it aims to answer is:
Is there is a significant difference in the esthetic outcome between bone augmentation alone and bone augmentation combined with connective tissue graft after immediate dental implant in the esthetic zone?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a non-restorable tooth or a remaining root without signs of acute infection in the maxillary esthetic zone.
- •The failing tooth is an incisor, canine or first bicuspid in the maxilla bounded by natural sound teeth.
- •Sufficient bone (>4 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥35 N cm).
- •Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
Exclusion Criteria
- •Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
- •Teeth with current acute periapical infection.
- •Dehiscence of the labial (facial) bone plate after extraction.
- •Signs of uncontrolled periodontal disease.
- •Heavy smokers and vulnerable groups (pregnant females and decision-impaired individuals).
- •History of head and neck radiation therapy.
Arms & Interventions
Hard tissue augmentation with connective tissue graft
Hard tissue augmentation (bone grafting) with additional connective tissue graft (CTG) performed at the same time following immediate dental implant in the esthetic zone
Intervention: Immediate dental implant in the esthetic zone (Procedure)
Hard tissue augmentation
Hard tissue augmentation (bone grafting) following immediate dental implant in the esthetic zone.
Intervention: Immediate dental implant in the esthetic zone (Procedure)
Outcomes
Primary Outcomes
Pink Esthetic Score (PES)
Time Frame: Pink esthetic score (PES) will be assessed at 6 months postoperatively.
Seven variables to be scored: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, alveolar process, soft tissue color, and texture of facial gingiva at the implant site. A score of 0, 1, or 2 will be given to each parameter to obtain a final score of 14.
Secondary Outcomes
- Patient satisfaction questionnaire(6 months postoperatively)
- Implant survival rate(6 months postoperatively)
- Rate of complications(From the intervention to 6 month postoperatively)
- Hard tissue assessment (facial bone thickness)(6 months postoperatively)
Investigators
Khalid Walid Khalid
Principal Investigator
University of Baghdad