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

Ain Shams University

Status: Enrolling

Conditions: Missing Tooth

Treatments: Other: Zirconia-based composite customized healing abutment; Other: Conventional composite customized healing abutment.

Study type: Interventional

Funder types: Other

Identifiers

NCT07095881

FDASU-REC 1437

Details and patient eligibility

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.

Full description

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Poor oral hygiene condition.
2. Pregnant and lactating females.
3. Smokers.
4. Vulnerable groups (Prisoners and handicaps).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Zirconia-based composite customized healing abutment

Active Comparator group

Description:

Participants in this arm will receive a customized healing abutment made of Zirconia-based composite material fabricated chairside. The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing. The abutment is placed immediately after implant placement and will remain in place for 3 months.

Treatment:

Other: Zirconia-based composite customized healing abutment

Conventional composite customized healing abutment

Active Comparator group

Description:

Participants in this arm will receive a customized healing abutment made of conventional composite material fabricated chairside. The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing. The abutment is placed immediately after implant placement and will remain in place for 3 months.

Treatment:

Other: Conventional composite customized healing abutment.