Influence of Zirconia Abutments on Peri-Implant Tissues in Single-Tooth Restorations

Официальное название

Potential Influence of Pre-fabricated and Customized Anatomical Zirconia Abutments in the Peri-implant Region for Single-tooth Implant-supported Prosthetic Restorations

Обзор

Objectives: To compare the influence of pre-fabricated titanium abutments and customized milled zirconia abutments on implant biocompatibility and the peri-implant region, as well as on radiographic bone loss and oral health-related quality of life. Detailed Methodology: This study is a randomized controlled clinical trial designed to evaluate the biological and clinical behavior of standardized titanium abutments compared with customized anatomical zirconia abutments in single implant-supported posterior restorations. The present investigation represents the prosthetic phase of a previously conducted randomized clinical trial that evaluated dimensional changes following different alveolar preservation protocols in posterior regions (CAAE: 59208422.8.0000.5418). In the previous phase, participants underwent tooth extraction and alveolar preservation procedures, followed by implant placement with Morse Taper (CM) implants (Biomorse XP, Bionnovation Biomedical) after a six-month healing period. After implant osseointegration, participants eligible for prosthetic rehabilitation will be randomly allocated to one of two parallel groups using a computer-generated randomization sequence (Sealedenvelope.com). The allocation ratio will be 1:1. Sample size calculation was performed using GPower software to ensure adequate statistical power. The intervention consists of prosthetic rehabilitation with either standardized titanium abutments (TiB group) or customized anatomical zirconia abutments (ZiT group), both supporting single zirconia crowns in posterior regions. All prosthetic and laboratory procedures will follow standardized clinical protocols. Clinical and laboratory assessments will be conducted at prosthesis delivery (baseline) and at 1-, 3-, 6-, and 12-month follow-up visits. Data collection will include peri-implant crevicular fluid (PICF) and biofilm sampling for biomolecular analysis, comprehensive periodontal clinical parameters, measurement of keratinized mucosa thickness, standardized periapical radiographs for marginal bone level assessment, and intraoral digital scanning for volumetric and soft tissue analysis. The primary objective is to compare peri-implant tissue stability and biological response between titanium and zirconia abutments. Secondary outcomes include clinical parameters, marginal bone level changes, and soft tissue dimensional stability over a 12-month follow-up period. This study aims to contribute to the understanding of how abutment material and design may influence peri-implant health and long-term tissue stability in posterior implant-supported restorations.

Подробное описание

This study is a randomized controlled clinical trial designed to evaluate the biological and clinical behavior of standardized titanium abutments compared with customized anatomical zirconia abutments in single implant-supported posterior restorations.

The present investigation represents the prosthetic phase of a previously conducted randomized clinical trial that evaluated dimensional changes following different alveolar preservation protocols in posterior regions (CAAE: 59208422.8.0000.5418). In the previous phase, participants underwent tooth extraction and alveolar preservation procedures, followed by implant placement with Morse Taper (CM) implants (Biomorse XP, Bionnovation Biomedical) after a six-month healing period.

After implant osseointegration, participants eligible for prosthetic rehabilitation will be randomly allocated to one of two parallel groups using a computer-generated randomization sequence (Sealedenvelope.com). The allocation ratio will be 1:1. Sample size calculation was performed using GPower software to ensure adequate statistical power.

The intervention consists of prosthetic rehabilitation with either standardized titanium abutments (TiB group) or customized anatomical zirconia abutments (ZiT group), both supporting single zirconia crowns in posterior regions. All prosthetic and laboratory procedures will follow standardized clinical protocols.

Clinical and laboratory assessments will be conducted at prosthesis delivery (baseline) and at 1-, 3-, 6-, and 12-month follow-up visits. Data collection will include:

Peri-implant crevicular fluid (PICF) and biofilm sampling for biomolecular analysis Comprehensive periodontal clinical parameters Measurement of keratinized mucosa thickness Standardized periapical radiographs for marginal bone level assessment Intraoral digital scanning for volumetric and soft tissue analysis The primary objective is to compare peri-implant tissue stability and biological response between titanium and zirconia abutments. Secondary outcomes include clinical parameters, marginal bone level changes, and soft tissue dimensional stability over a 12-month follow-up period.

This study aims to contribute to the understanding of how abutment material and design may influence peri-implant health and long-term tissue stability in posterior implant-supported restorations.

Вмешательства

• Устройство Pre-fabricated standardized titanium abutments
  Participants receive prosthetic rehabilitation with manufacturer-provided pre-fabricated standardized titanium abutments connected to previously osseointegrated Morse Taper implants. After abutment placement, single zirconia crowns are installed following standardized digital prosthetic procedures.
• Устройство Customized anatomical zirconia abutments
  Participants receive prosthetic rehabilitation with CAD/CAM-fabricated customized anatomical zirconia abutments connected to previously osseointegrated Morse Taper implants. After abutment placement, single zirconia crowns are installed following standardized digital prosthetic procedures.

Первичные конечные точки

• Microbial Colonization in Peri-implant Sites [Срок оценки: 1, 3, 6, and 12 months after prosthesis installation]

Вторичные конечные точки (1)

• Demographic Characteristics of the Study Population [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Individuals aged 18 years or older;
• Participants in the Master's Thesis entitled: "Dimensional Changes Following Different Alveolar Preservation Protocols in Posterior Regions: A Randomized Controlled Study";
• Patients with implants and healing abutments from Bionnovation Biomedical in place at the time of prosthetic rehabilitation;
• Implants without surrounding bone loss;
• Signed informed consent form.

Критерии исключения

• Patients with uncontrolled systemic diseases;
• Pregnant or lactating women;
• Smokers or former smokers;
• Undergoing orthodontic treatment;
• Using medications that interfere with bone healing, such as those for osteoporosis and bisphosphonates;
• Implants with bone loss or failed implants.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Piracicaba Dental School — Piracicaba

Публикации

• Bouri A Jr, Bissada N, Al-Zahrani MS, Faddoul F, Nouneh I. Width of keratinized gingiva and the health status of the supporting tissues around dental implants. Int J Oral Maxillofac Implants. 2008 Mar-Apr;23(2):323-6. PMID 18548930
• Koutouzis T. Implant-abutment connection as contributing factor to peri-implant diseases. Periodontol 2000. 2019 Oct;81(1):152-166. doi: 10.1111/prd.12289. PMID 31407436
• Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available. PMID 4924041
• Kumar PS. Systemic Risk Factors for the Development of Periimplant Diseases. Implant Dent. 2019 Apr;28(2):115-119. doi: 10.1097/ID.0000000000000873. PMID 30893143
• Berglundh T, Lindhe J, Ericsson I, Marinello CP, Liljenberg B, Thomsen P. The soft tissue barrier at implants and teeth. Clin Oral Implants Res. 1991 Apr-Jun;2(2):81-90. doi: 10.1034/j.1600-0501.1991.020206.x. PMID 1809403
• Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x. PMID 18724855
• Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350. PMID 29926957
• Lang NP, Berglundh T; Working Group 4 of Seventh European Workshop on Periodontology. Periimplant diseases: where are we now?--Consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol. 2011 Mar;38 Suppl 11:178-81. doi: 10.1111/j.1600-051X.2010.01674.x. PMID 21323713

Идентификаторы

NCT: NCT07456163 · 86486425.5.0000.5418

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗