Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07095881

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Missing Tooth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Ain Shams University

Cairo, Abaseya, 7154411, Egypt

Location status: Recruiting

Location contact

Ahmed A El Sayed, MSc Perio

PRINCIPAL_INVESTIGATOR

Dean of the faculty

CONTACT

[email protected]

+20222639083

About this study

Light-cured direct zirconia-based composite has many potential uses in dentistry, because of mechanical and biological reasons maintaining the health of peri-implant soft tissues during healing.

Direct zirconia-based composite customized healing abutments have superior properties such as biocompatibility, chemical stability, antibacterial and mechanical properties.

Aim of the study: This study will be carried out to compare zirconia-based composite customized healing abutments vs conventional composite customized healing abutment placed simultaneously with delayed dental implant placement.

Materials and Methods: This will be done by clinical evaluation of peri-implant soft tissue changes. Moreover, peri-implant sulcus fluid (PISF) will be measured for the level of Interleukin-1 beta (IL-1β) in the gingival crevicular fluid.

PICOTS Elements:

Patient/Problem:Patients that are eligible for implant placement within inclusion criteria.

Intervention: Zirconia-based composite customized healing abutment. Comparator: Conventional composite customized healing abutment.

Outcome:

Primary outcome : Clinical evaluation of peri-implant soft tissue changes via pink esthetic score and papilla index.

Secondary outcome : Biochemical assessment of IL-1β level in the gingival crevicular fluid using Periopaper strip .

Time: Baseline, 1,2 and 3 months after implantation. Biochemical assessment : after 2 months of implantation. Setting: Faculty of Dentistry, Ain Shams University. Clinical Relevance: The result will affect the gold standard in choosing the customized healing abutment material for implant patients, regarding which one offers better peri-implant soft tissue results, healing stimulation, and less inflammatory response.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire (Pendleton et al., 2004).
  • Both genders.
  • Age from 20-50 years.
  • Missing tooth to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures (Beretta et al., 2019).
  • Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor (Baltayan et al., 2016).
  • Sound Mesial and distal neighboring teeth.
  • At least 6 natural teeth remaining in the same arch .
  • Mouth opening ≥ 30mm.
  • Thick phenotype.

Exclusion criteria

  • Poor oral hygiene condition.
  • Pregnant and lactating females.
  • Smokers.
  • Vulnerable groups (Prisoners and handicaps).

Treatment and study plan

Zirconia-based composite customized healing abutment

Other

using Zirconia-based composite in customized healing abutment fabrication

Conventional composite customized healing abutment.

Other

using conventional composite in customized healing abutment fabrication

Primary outcomes

  1. Pink Esthetic Score

    Time frame: Baseline, 1,2 and 3 months after implantation.

    The Pink Esthetic Score is used to evaluate the soft tissue esthetics around single-tooth implants.

    It includes 7 parameters: mesial and distal papilla, tissue contours, gingival level, alveolar process, and both the color and texture of the soft tissue. Each is scored from 0 to 2, with higher scores reflecting more natural esthetics. For the papillae, a score of 0 indicates the papilla is missing, 1 is incomplete, and 2 is complete. Tissue contours are rated as unnatural (0), virtually natural (1), or natural (2). Gingival level is assessed based on vertical discrepancy with adjacent teeth: more than 2 mm scores 0, 1-2 mm scores 1, and less than 1 mm scores 2. The alveolar process is scored as clearly resorbed (0), slightly resorbed (1), or showing no difference (2). Finally, both soft tissue color and texture are evaluated against the neighboring tissue: a clear difference (0), a slight difference (1),no difference (2). The maximum PES is 14, represents ideal soft tissue esthetics.

  2. Papilla index

    Time frame: baseline, 1,2 and 3 months

    The Papilla Index is a clinical tool used to evaluate the degree of interdental papilla fill in the proximal space around implants.

    It is scored on a scale from 0 to 4. A score of 0 indicates that no papilla is present. A score of 1 means less than half of the papilla height is visible. A score of 2 is assigned when half or more of the papilla height is present, though not completely filling the space.

    A score of 3 denotes a papilla that fully occupies the entire proximal space, representing the ideal scenario.

    A score of 4 indicates a hyperplastic papilla, where the tissue extends beyond the normal contours.

Secondary outcomes

  1. Biochemical assessment of IL-1β level in the gingival crevicular fluid

    Time frame: After 2 months of implant placement

    Biochemical assessment of IL-1β level in the gingival crevicular fluid using Periopaper strip.

Study contacts

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

Ahmed A El Sayed, MSc Perio

CONTACT

[email protected]

+201127999187

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment: A Randomized Controlled Clinical Study With Biochemical Analysis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.