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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Other Zirconia-based composite customized healing abutment
  using Zirconia-based composite in customized healing abutment fabrication
• Other Conventional composite customized healing abutment.
  using conventional composite in customized healing abutment fabrication

Primary outcome measures

• Pink Esthetic Score [Time frame: Baseline, 1,2 and 3 months after implantation.]
• Papilla index [Time frame: baseline, 1,2 and 3 months]

Secondary outcome measures (1)

• Biochemical assessment of IL-1β level in the gingival crevicular fluid [Time frame: After 2 months of implant placement]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry Ain Shams University — Cairo

Publications

• Pendleton N, Clague JE, Horan MA, Rabbitt PM, Jones M, Coward R, Lowe C, McInnes L. Concordance of Cornell medical index self-reports to structured clinical assessment for the identification of physical health status. Arch Gerontol Geriatr. 2004 May-Jun;38(3):261-9. doi: 10.1016/j.archger.2003.10.005. PMID 15066312
• Lashkarizadeh N, Foroudisefat M, Abyari S, Mohammadi M, Lashkarizadeh L. Is It Safe to Reuse Healing Abutments? An Experimental Study on IL-1beta and TNF-alpha Cytokine Levels in Peri-Implant Crevicular Fluid. J Prosthodont. 2022 Jun;31(5):399-404. doi: 10.1111/jopr.13474. Epub 2022 Feb 19. PMID 34962679
• Kunrath MF, Gupta S, Lorusso F, Scarano A, Noumbissi S. Oral Tissue Interactions and Cellular Response to Zirconia Implant-Prosthetic Components: A Critical Review. Materials (Basel). 2021 May 25;14(11):2825. doi: 10.3390/ma14112825. PMID 34070589
• Khatri M, Bansal M, Puri K, Mehrotra S, Kumar A, Rehan M. Evaluation of the correlation between interleukin 1beta levels in peri-implant crevicular fluid as an adjunctive diagnostic marker with clinical and radiographic parameters for assessing the peri-implant health status. Natl J Maxillofac Surg. 2022 Sep-Dec;13(3):421-429. doi: 10.4103/njms.njms_337_21. Epub 2022 Dec 10. PMID 36683945
• Chokaree P, Poovarodom P, Chaijareenont P, Yavirach A, Rungsiyakull P. Biomaterials and Clinical Applications of Customized Healing Abutment-A Narrative Review. J Funct Biomater. 2022 Dec 10;13(4):291. doi: 10.3390/jfb13040291. PMID 36547551
• Beretta M, Poli PP, Pieriboni S, Tansella S, Manfredini M, Cicciu M, Maiorana C. Peri-Implant Soft Tissue Conditioning by Means of Customized Healing Abutment: A Randomized Controlled Clinical Trial. Materials (Basel). 2019 Sep 19;12(18):3041. doi: 10.3390/ma12183041. PMID 31546800
• Bannunah AM. Biomedical Applications of Zirconia-Based Nanomaterials: Challenges and Future Perspectives. Molecules. 2023 Jul 15;28(14):5428. doi: 10.3390/molecules28145428. PMID 37513299
• Baltayan S, Pi-Anfruns J, Aghaloo T, Moy PK. The Predictive Value of Resonance Frequency Analysis Measurements in the Surgical Placement and Loading of Endosseous Implants. J Oral Maxillofac Surg. 2016 Jun;74(6):1145-52. doi: 10.1016/j.joms.2016.01.048. Epub 2016 Feb 1. PMID 26917203

Identifiers

NCT: NCT07095881 · FDASU-REC 1437

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗