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NCT Number: NCT07333534

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

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?

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Key information

Conditions

Dental Implant

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Baghdad/ College of Dentistry/ Department of Oral and Maxillofacial surgery/ Implant Unit

Baghdad, Rusafa, 10047, Iraq

Location status: Recruiting

Location contact

Hassanien Al-Jumaily

CONTACT

[email protected]

+9647708896181

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate dental implant in the esthetic zone

Procedure

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

Primary outcomes

  1. 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

  1. 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.

  2. 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].

  3. 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).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Khalid Khalid, Bachelor of Dental Surgery

CONTACT

[email protected]

+9647716641706

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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