Actively Recruiting

Phase Not Applicable
Age: 20Years - 50Years
All Genders
NCT07095881

Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment

Led by Ain Shams University · Updated on 2025-07-31

22

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if using zirconia-based composite customized healing abutment can have a favorable effect on peri implant soft tissue that may be related to the superior biological properties of zirconium nano particles regarding increased biocompatibility and decreased inflammatory response Patients that are eligible for implant placement The main question it aims to answer is: Does zirconia-based composite customized healing abutment have a significantly different effect on peri-implant soft tissue compared to conventional composite customized healing abutment in terms of biological properties or biocompatibility or inflammatory response? Researchers will compare between direct zirconia-based composite customized healing abutments vs conventional composite customized healing abutments placed simultaneously with delayed dental implant placement. Participants will be undergo the following procedures : A) Presurgical procedures: 1. Detailed clinical examination, full history, and radiographic examination (CBCT) will be performed initially to aid in patients' selection. 2. After enrollment, all participants will sign the informed consent. 3. All participants will be subjected to periodontal phase I treatment including periodontal supra- and sub-gingival debridement and oral hygiene instructions. B) Surgical procedures: 1. After local anesthesia administration, flap is raised, osteotomy site preparation, and implant will be placed. 2. Check the ISQ to exceed or equal 70 unit. 3. A customized Light-cured Direct Zirconia-Based Composite or A customized Light-cured Direct Convential Composite Healing Abutment will be placed. Then all participants should follow up at the following times : Baseline, 1,2 and 3 months after implantation.

CONDITIONS

Official Title

Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment

Who Can Participate

Age: 20Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be free from systemic diseases based on the Cornell Medical Index-Health Questionnaire.
  • Both genders are eligible.
  • Age between 20 and 50 years.
  • Presence of a missing tooth to be restored with a standard implant without need for additional bone or soft tissue augmentation.
  • Implant primary stability (ISQ) of 70 units or higher.
  • Sound mesial and distal neighboring teeth.
  • At least 6 natural teeth remaining in the same arch.
  • Mouth opening of at least 30 mm.
  • Thick soft tissue phenotype.
Not Eligible

You will not qualify if you...

  • Poor oral hygiene condition.
  • Pregnant or lactating females.
  • Smokers.
  • Vulnerable groups such as prisoners and handicapped individuals.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Dentistry Ain Shams University

Cairo, Abaseya, Egypt, 7154411

Actively Recruiting

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Research Team

A

Ahmed A El Sayed, MSc Perio

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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