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

NCT07095881 | Recruiting DMC

• 1 other identifier: FDASU-REC 1437
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Detailed clinical examination, full history, and radiographic examination (CBCT) will be performed initially to aid in patients' selection.
2. 2.After enrollment, all participants will sign the informed consent.
3. 3.All participants will be subjected to periodontal phase I treatment including periodontal supra- and sub-gingival debridement and oral hygiene instructions.
4. 4.After local anesthesia administration, flap is raised, osteotomy site preparation, and implant will be placed.
5. 5.Check the ISQ to exceed or equal 70 unit.
6. 6.A customized Light-cured Direct Zirconia-Based Composite or A customized Light-cured Direct Convential Composite Healing Abutment will be placed.

Conditions

Missing Tooth

Keywords

Implant; dental implant; Delayed implant; Healing abutment; Customized healing abutment; Zirconia-based composite customized healing abutment; Conventional composite customized healing abutment; Biochemical Analysis; Pink esthetic Score; Papilla index; PISF samples; IL-1β

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

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

  After 2 months of implant placement

Study Arms (2)

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.

Other: Zirconia-based composite customized healing abutment

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.

Other: Conventional composite customized healing abutment.

Interventions

Zirconia-based composite customized healing abutment OTHER

using Zirconia-based composite in customized healing abutment fabrication

Zirconia-based composite customized healing abutment

Conventional composite customized healing abutment. OTHER

using conventional composite in customized healing abutment fabrication

Conventional composite customized healing abutment

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Abaseya, 7154411, Egypt

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 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.

  PMID: 34070589 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.

  PMID: 36683945 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.

  PMID: 36547551 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.

  PMID: 31546800 BACKGROUND

• 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 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.

  PMID: 26917203 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.

  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.

  PMID: 34361359 BACKGROUND

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

Central Study Contacts

Ahmed A El Sayed, MSc Perio

CONTACT

+201127999187; ahmed.abdelmoteleb.std@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, controlled, parallel design, two arms clinical trial

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 31, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)