Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment
NCT ID: NCT07095881
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
22 participants
INTERVENTIONAL
2025-01-06
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Zirconia-based composite customized healing abutment
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.
Zirconia-based composite customized healing abutment
using Zirconia-based composite in customized healing abutment fabrication
Conventional composite customized healing abutment
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.
Conventional composite customized healing abutment.
using conventional composite in customized healing abutment fabrication
Interventions
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Zirconia-based composite customized healing abutment
using Zirconia-based composite in customized healing abutment fabrication
Conventional composite customized healing abutment.
using conventional composite in customized healing abutment fabrication
Eligibility Criteria
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Inclusion Criteria
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
2. Pregnant and lactating females.
3. Smokers.
4. Vulnerable groups (Prisoners and handicaps).
20 Years
50 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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ahmed asem elsayed abd elmoteleb
Principal Investigator
Principal Investigators
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Hadeel G Salem, Lecturer
Role: STUDY_DIRECTOR
Faculty of Dentistry - Ain Shams University
Nevine H Kheir El Din, Professor
Role: STUDY_DIRECTOR
Faculty of Dentistry - Ain Shams University
Locations
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Faculty of Dentistry Ain Shams University
Cairo, Abaseya, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Bannunah AM. Biomedical Applications of Zirconia-Based Nanomaterials: Challenges and Future Perspectives. Molecules. 2023 Jul 15;28(14):5428. doi: 10.3390/molecules28145428.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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FDASU-REC 1437
Identifier Type: -
Identifier Source: org_study_id
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