Hard Tissue Augmentation With or Without Connective Tissue Graft in Immediate Esthetic Implants

N/ANot Yet RecruitingNCT07333534

University of Baghdad28 enrolled

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Implant

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pink Esthetic Score (PES)

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.

Time frame: Pink esthetic score (PES) will be assessed at 6 months postoperatively.

Secondary Outcomes

Hard tissue assessment (facial bone thickness)

Using Cone-Beam Computed Tomography (CBCT) to assess the thickness of the facial (labial/buccal) plate of bone at two points: the implant platform and a point 5mm apical to the implant platform.

Time frame: 6 months postoperatively

Patient satisfaction questionnaire

Assessment of patient satisfaction will be performed at 6 months postoperatively with a self-administered patient questionnaire regarding overall satisfaction and satisfaction of color and shape of the mucosa using a visual analogue scale (VAS, left = very dissatisfied \[0\], right = very satisfied \[10\].

Time frame: 6 months postoperatively

Implant survival rate

Implant survival rate at 6 months (defined by absence of mobility, infection, pain, and peri-implant bone loss).

Time frame: 6 months postoperatively

Rate of complications

complications such as infection, graft rejection and peri-implantitis will be assessed from the intervention up to 6 months postoperatively.

Time frame: From the intervention to 6 month postoperatively

Hard Tissue Augmentation With or Without Connective Tissue Graft in Immediate Esthetic Implants

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts