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

NCT07333534 | Recruiting

• 1 other identifier: 973124
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Dental Implant

Keywords

immediate implant; maxillary esthetic zone; CTG; jumping gap; bone augmentation

Outcome Measures

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.

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

Secondary Outcomes (4)

• Hard tissue assessment (facial bone thickness)

  6 months postoperatively

• Patient satisfaction questionnaire

  6 months postoperatively

• Implant survival rate

  6 months postoperatively

• Rate of complications

  From the intervention to 6 month postoperatively

Study Arms (2)

Hard tissue augmentation with connective tissue graft

EXPERIMENTAL

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

Hard tissue augmentation

ACTIVE COMPARATOR

Hard tissue augmentation (bone grafting) following immediate dental implant in the esthetic zone.

Procedure: Immediate dental implant in the esthetic zone

Interventions

Immediate dental implant in the esthetic zone PROCEDURE

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

Hard tissue augmentation; Hard tissue augmentation with connective tissue graft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

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

Baghdad, Rusafa, 10047, Iraq

RECRUITING

Central Study Contacts

Khalid Khalid, Bachelor of Dental Surgery

CONTACT

+9647716641706; khaled.waleed2408m@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 12, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-11

Locations

IR (1)