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Clinical Trials/NCT07333534
NCT07333534RecruitingNot Applicable

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

University of Baghdad1 site in 1 country28 target enrollmentStarted: December 20, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
28
Locations
1
Primary Endpoint
Pink Esthetic Score (PES)

Study Overview

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?

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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

Intervention: Immediate dental implant in the esthetic zone (Procedure)

Hard tissue augmentation

Active Comparator

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

Intervention: Immediate dental implant in the esthetic zone (Procedure)

Outcomes

Primary Outcomes

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

  • Patient satisfaction questionnaire(6 months postoperatively)
  • Implant survival rate(6 months postoperatively)
  • Rate of complications(From the intervention to 6 month postoperatively)
  • Hard tissue assessment (facial bone thickness)(6 months postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khalid Walid Khalid

Principal Investigator

University of Baghdad

Study Sites (1)

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