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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:
B) Surgical procedures:
Then all participants should follow up at the following times : Baseline, 1,2 and 3 months after implantation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zirconia-based composite customized healing abutment | Active Comparator | 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. |
|
| Conventional composite customized healing abutment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zirconia-based composite customized healing abutment | Other | using Zirconia-based composite in customized healing abutment fabrication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pink Esthetic Score | 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. | Baseline, 1,2 and 3 months after implantation. |
| Papilla index | 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. | baseline, 1,2 and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical assessment of IL-1β level in the gingival crevicular fluid | Biochemical assessment of IL-1β level in the gingival crevicular fluid using Periopaper strip. | After 2 months of implant placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed A El Sayed, MSc Perio | Contact | +201127999187 | ahmed.abdelmoteleb.std@dent.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hadeel G Salem, Lecturer | Faculty of Dentistry - Ain Shams University | Study Director |
| Nevine H Kheir El Din, Professor | Faculty of Dentistry - Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Ain Shams University | Recruiting | Cairo | Abaseya | 7154411 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15066312 | Background | 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. | |
| 34962679 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2025 | Jul 29, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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Randomized, controlled, parallel design, two arms clinical trial
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| Conventional composite customized healing abutment. | Other | using conventional composite in customized healing abutment fabrication |
|
| 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. |
| 34070589 | Background | 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. |
| 36683945 | Background | 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. |
| 36547551 | Background | 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. |
| 31546800 | Background | 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. |
| 37513299 | Background | Bannunah AM. Biomedical Applications of Zirconia-Based Nanomaterials: Challenges and Future Perspectives. Molecules. 2023 Jul 15;28(14):5428. doi: 10.3390/molecules28145428. |
| 26917203 | Background | 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. |
| Background | Almadani, T. M., Amer, A.-F. M., Abdallah, H. M., & El Sayed, I. S. Clinical and radiographic evaluation of peri-implant tissue changes associated with use of standard versus customized healing abutments. Al-Azhar Journal of Dental Science (2023), 26(2), 229-239. |
| 34361359 | Background | Ramenzoni LL, Fluckiger LB, Attin T, Schmidlin PR. Effect of Titanium and Zirconium Oxide Microparticles on Pro-Inflammatory Response in Human Macrophages under Induced Sterile Inflammation: An In Vitro Study. Materials (Basel). 2021 Jul 27;14(15):4166. doi: 10.3390/ma14154166. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |