Hard Tissue Augmentation With or Without Connective Tissue Graft in Immediate Esthetic Implants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immediate dental implant in the esthetic zone.
- Who it may be relevant to
- Registry conditions: Dental Implant. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Hard Tissue Augmentation With or Without Connective Tissue Graft Following Immediate Dental Implants in the Esthetic Zone: A Randomized Controlled Study
Overview
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?
Interventions
- Procedure Immediate dental implant in the esthetic zone
Placement of immediate dental implant after tooth extraction in the maxillary esthetic zone.
Primary outcome measures
- Pink Esthetic Score (PES) [Time frame: Pink esthetic score (PES) will be assessed at 6 months postoperatively.]
Secondary outcome measures (4)
- Hard tissue assessment (facial bone thickness) [Time frame: 6 months postoperatively]
- Patient satisfaction questionnaire [Time frame: 6 months postoperatively]
- Implant survival rate [Time frame: 6 months postoperatively]
- Rate of complications [Time frame: From the intervention to 6 month postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- University of Baghdad/ College of Dentistry/ Department of Oral and Maxillofacial surgery/ — Baghdad
Identifiers
NCT: NCT07333534 · 973124