Health TrialsbyHealthPanel

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

ConditionDental Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Baghdad

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate dental implant in the esthetic zone

    Procedure/Surgery

    Placement of immediate dental implant after tooth extraction in the maxillary esthetic zone.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Hard tissue augmentation with connective tissue graftExperimental treatment 1 intervention
Group B: Hard tissue augmentationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Baghdad

Lead sponsor

Source ClinicalTrials.gov
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