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

March 12, 2026 updated by: Khalid Walid Khalid, University of Baghdad

Effectiveness of Hard Tissue Augmentation With or Without Connective Tissue Graft Following Immediate Dental Implants in the Esthetic Zone: A Randomized Controlled Study

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
    • Rusafa
      • Baghdad, Rusafa, Iraq, 10047
        • Recruiting
        • University of Baghdad/ College of Dentistry/ Department of Oral and Maxillofacial surgery/ Implant Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Immediate dental implant in the esthetic zone
Placement of immediate dental implant after tooth extraction in the maxillary esthetic zone.
Active Comparator: Hard tissue augmentation
Hard tissue augmentation (bone grafting) following immediate dental implant in the esthetic zone.
Procedure: Immediate dental implant in the esthetic zone
Placement of immediate dental implant after tooth extraction in the maxillary esthetic zone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pink esthetic score (PES) will be assessed at 6 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction questionnaire
Time Frame: 6 months postoperatively
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].
6 months postoperatively
Implant survival rate
Time Frame: 6 months postoperatively
Implant survival rate at 6 months (defined by absence of mobility, infection, pain, and peri-implant bone loss).
6 months postoperatively
Rate of complications
Time Frame: From the intervention to 6 month postoperatively
complications such as infection, graft rejection and peri-implantitis will be assessed from the intervention up to 6 months postoperatively.
From the intervention to 6 month postoperatively
Hard tissue assessment (facial bone thickness)
Time Frame: 6 months postoperatively
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.
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 973124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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