Clinical Oral Implants Research最新文献

Background: This study aims to examine commonly used patient-reported outcomes (PROs) and outcome measures (PROMs) alongside clinician-reported outcomes (ClinROs) in individuals with an edentulous maxilla initially rehabilitated with conventional complete dentures (CDs) and later transitioned to implant-retained overdentures (IODs).

Material and methods: An electronic search of three databases and a manual search were conducted for relevant articles between January 2014 and June 2024. Eligible studies included patients with an edentulous maxilla or those scheduled for extraction of all maxillary teeth, treated with CDs and subsequently transitioned to IODs, and reported PROs and ClinROs.

Results: Nine articles, including five randomized controlled trials and four prospective cohort studies, were selected for descriptive analyses. Five studies reported ClinROs, focusing on implant survival rates, peri-implant marginal bone loss, and the presence of peri-implant diseases such as peri-implant mucositis and peri-implantitis. PROs varied across studies, with assessments including oral health-related quality of life, patient satisfaction, and specific PROs such as comfort, stability, ability to chew, speech, and esthetics. Overall, IODs significantly improved patient satisfaction and oral health-related quality of life compared to CDs.

Conclusion: For patients initially rehabilitated with conventional CDs and later transitioned to IODs, oral health-related quality of life is the most frequently reported PRO, followed by patient satisfaction. Regarding ClinROs, the implant survival rate is the most commonly investigated outcome, with peri-implant marginal bone loss, denture survival rate, and prosthetic complications being the next most frequently reported ClinROs. Additionally, implant complications and the presence of peri-implant diseases are commonly documented.

Objectives: To gather perspectives from patients and cross-disciplinary experts on treatment practices and outcomes in managing the edentulous maxilla to inform a structured consensus process and highlight areas for future research.

Materials and methods: An 18-item single-round survey was distributed in November 2024 with 68 patients and 68 cross-disciplinary experts. Participation was voluntary, anonymous, incentive-free, and required informed consent. Consensus was defined as > 75% and ≤ 95% agreement or disagreement, and strong consensus as > 95% agreement or disagreement.

Results: Response rates were 60.3% among patients, and 30.9% among cross-disciplinary experts. Consensus or strong consensus was achieved by patients on 15 statements across nine items and by cross-disciplinary experts on 15 statements across eight items. Items reaching consensus included the use of cone-beam computed tomography, preference for fixed full-arch prostheses, major treatment outcomes, need for hard tissue augmentation, home care regimens, dental implant lifespan, procedure difficulty, cost-effectiveness, and patient-reported outcomes. Both groups also highlighted the need for further research on full-arch implant rehabilitation of the maxilla.

Conclusion: Findings from both surveys inform the development of clinical practice guidelines in treating the edentulous maxilla by providing valuable perspectives from patients and cross-disciplinary experts. Areas lacking consensus illustrate real-world variations in treatment approaches, highlight knowledge gaps in the current literature, and reveal important differences among patient expectations, expert opinions, and available evidence.

Precise terminology and a clear distinction between what is measured (outcomes) and how it is measured (outcome assessments) are fundamental in implant dentistry (ID) research. This narrative review defines outcomes and outcome assessments and aligns ID terminology with established regulatory frameworks. We map survival outcomes, biomarkers, and the four FDA-recognized clinical outcome assessments (COAs) patient-reported, clinician-reported, observer-reported, and performance outcomes onto a spectrum defined by patient meaningfulness and the need for human judgment. Definitive events (e.g., implant loss) sit at one end of the spectrum, and purely objective biomarkers (e.g., dimensional ridge changes) sit at the other end, while COAs occupy the middle of that spectrum. Content validity is essential for any COA. Tools must be co-developed with people with lived experience (PWLE) and evaluated with Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) standards to ensure they truly measure the intended construct, in the right population, with adequate reliability, responsiveness, and interpretability. Finally, we caution against conflating measures (tools, e.g., radiography) with endpoints (prespecified analysis variables with time frame and threshold). Using standardized definitions in present and future ID consensus statements will increase their meaningfulness and strengthen the relevance and comparability of clinical trials.

Objectives: The objective of this survey study was to collect expert insights on the rehabilitation of the edentulous maxilla involving adjunctive procedures such as sinus lifts and other bone augmentation techniques. This process aimed to support the development of a consensus and contribute to the formulation of clinical practice guidelines for the management of the edentulous maxilla.

Materials and methods: In preparation for the 1st Global Consensus for Clinical Guidelines for the rehabilitation of the edentulous maxilla, a structured questionnaire was developed. The survey was administered online anonymously in a single round. It consisted of multiple-choice items and 94 7-point Likert-scale statements and questions. Consensus was defined as >75% and ≤95% agreement or disagreement, and strong consensus as >95% agreement or disagreement.

Results: Of the 217 experts invited from 43 countries, 116 successfully completed the questionnaire via the survey link, resulting in a response rate of 53.5%. Among the 94 statements and questions, 44 (46.8%) reached consensus and 4 (4.3%) strong consensus. All statements that achieved strong consensus pertained to key clinician-reported outcomes considered essential for inclusion in future research. There was strong agreement on the importance of evaluating surgical, prosthetic, and biological complications, along with marginal bone loss.

Conclusion: This study collected valuable expert opinions to inform a consensus development process and contribute to the formulation of clinical practice guidelines for the management of the edentulous maxilla in complex cases requiring additional augmentation procedures.

Objectives: To gather the opinions and preferences of experts regarding the number of implants used to support a fixed prosthesis in the edentulous maxilla, timing of implant placement, and timing of implant loading. This was performed using a single-round survey methodology. The primary objective was to support the development of a consensus and contribute to the formulation of clinical practice guidelines for the management of the edentulous maxilla.

Materials and methods: A custom survey instrument was created by a steering committee and team of experts for the 1st Global Consensus for Clinical Guidelines. The anonymous survey was conducted using a single-round survey method. Consensus was defined as > 75% and ≤ 95% agreement or disagreement, and strong consensus as > 95% agreement or disagreement.

Results: A total of 202 experts from 42 different countries were identified and invited to participate. 117 provided consent and completed the questionnaire, resulting in a response rate of 57.9%. Strong consensus (> 95%) reached on no items. Consensus (> 75% and ≤ 95%) reached on four items: always using CBCT for planning, first molar as distal-most implant site for full-arch fixed prosthesis, use of a lab-fabricated acrylic provisional for full-arch fixed prosthesis, and the use of 4 implants to retain a removable maxillary denture.

Conclusion: This survey synthesized the preferences and opinions of experts regarding implant number, timing, and loading for the fixed rehabilitation of the edentulous maxilla to inform a consensus development process and contribute to the formulation of clinical practice guidelines for the management of the edentulous maxilla.

Aim: To identify patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs) and their outcome measures (PROMs and CROMs) used in prospective studies comparing immediate, early, and delayed implant loading protocols in edentulous maxilla patients receiving implant-supported prostheses.

Materials and methods: Protocol-driven electronic searches were conducted across MEDLINE, Embase, Scopus, Web of Science, Cochrane databases-January 2014 to May 2024-to identify prospective interventional and observational studies comparing immediate, early, delayed implant loading in maxillary edentulous patients. Zygomatic implants were excluded. Risk of bias was performed using Cochrane RoB 2 and ROBINS-I, and results were reported descriptively.

Results: Five studies were included, of which four compared immediate versus delayed loading and one study compared immediate versus early loading. PROMs like visual analog scale (VAS) tool (reported in 80%) to evaluate 7 PROs: pain, overall satisfaction, comfort, speech, masticatory function, esthetics, and self-esteem. Three studies reported Oral Health Impact Profile (OHIP-19, OHIP-20), McGill Pain Questionnaire, and condition-specific instruments assessing two outcomes: chewing ability and muscular activity during oral functions. ClinROs varied considerably between studies, demonstrating significant methodological diversity. ClinROs included implant stability, accuracy, occlusal parameters, periodontal health metrics, surgical outcomes, and esthetic evaluation via VAS.

Conclusion: PROs were predominantly assessed using VAS to evaluate patient satisfaction, pain, function, and esthetics, followed by the OHIP Questionnaire for quality-of-life assessment in immediate versus early/delayed loading protocols. ClinROs showed no standardized approach, creating significant heterogeneity in the reported outcomes. Standardization of assessment methods and reporting of PROMs/CROMs is needed to optimize analyzing patient-centered outcomes.

Objectives: Rehabilitation of the edentulous maxilla poses major clinical and patient-centered challenges. While implant survival and marginal bone level changes dominate the literature, patient-reported outcomes (PROs) such as aesthetic satisfaction, comfort, and quality of life remain underrepresented. The Global Consensus for Clinical Guidelines (GCCG) aimed to develop an international, consensus-based guideline for maxillary rehabilitation that integrates PROs and clinician-reported outcomes (ClinROs) within a structured treatment workflow and to identify future research priorities.

Materials and methods: This S2k-level guideline was developed through a multi-phase process involving clinical experts, a methodologist, patients, and interdisciplinary contributors. Evidence synthesis included eight systematic reviews and six structured surveys. A Core Outcome Set (COS) of 34 critically important outcomes (10 PROs, 22 objective and 2 subjective ClinROs) was established via a three-round Delphi process with 105 experts. Consensus recommendations were generated and voted upon by 105 delegates from 26 countries using nominal group technique and anonymous plenary voting.

Results: The guideline defines 36 consensus-based recommendations mapped to 34 COS outcomes, covering all phases of care, patient selection, diagnostics, surgical and prosthetic treatment, complication management, and maintenance. It emphasizes shared decision-making, prosthetically driven planning, immediate protocols when feasible, and risk-based maintenance to prevent surgical, biological, and technical complications. A clinical workflow checklist and decision trees support practical implementation.

Conclusions: This is the first global guideline for edentulous maxilla rehabilitation integrating a COS across all treatment phases, fostering evidence-based, outcome-driven, and patient-centered implant care worldwide.

Aim: To identify patient- and clinician-reported outcomes (PROs and ClinROs) and methods of assessment in clinical trials involving short and/or standard-length and/or zygomatic implants supporting maxillary implant overdentures (IODs).

Materials and methods: A systematic search was conducted in PubMed, EMBASE, Scopus, Web of Science CENTRAL, and National clinical trial register for articles published between January 1, 2014, and March 23, 2024. Studies that included PROs and ClinROs for implant therapy in patients with edentulous maxillae were eligible, and study quality was appraised using the Cochrane Risk of Bias 2 tool, Newcastle-Ottawa Scale, or Joanna Briggs Institute Critical tool.

Results: A total of 2331 articles were screened, resulting in 21 studies representing 14 patient cohorts with 462 participants and 2140 implants. Two studies used short implants (6 mm) with standard-length implants, while the remaining 19 studies focused exclusively on standard-length implants (7-14 mm); none included zygomatic implants. Patient-reported outcome measures (PROMs) varied widely: Oral Health Impact Profile questionnaires and visual analogue scales were each used in eight studies, and eleven studies relied on unstandardized questionnaires. Implant survival rate was the most frequently used ClinRO, included in all but one study. Subjective ClinROs based on clinician perception were absent in all studies.

Conclusions: Although PROMs were frequently employed in clinical trials, the lack of standardization hinders meaningful comparisons across studies. While objective ClinROs were commonly reported, subjective ClinROs reflecting clinicians' perceptions were notably absent.

Aim: To address what patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs) have been reported, and what measures (PROMs and CROMs) have been used to assess them in clinical studies on the timing of implant placement in the edentulous maxilla?

Materials and methods: Systematic searches were conducted in five databases to identify longitudinal prospective clinical studies. PROMs, CROMs, and methods were extracted. Risk of bias was assessed based on study design, and outcomes were analyzed descriptively.

Results: Thirteen studies were included: 1 randomized controlled trial and 12 case series. Delayed placement was reported in 9 studies, immediate in 2, and both in 2. Regarding PROs, 16 outcomes were identified, including oral health-related quality of life (reported in 53.85%), pain intensity (38.46%), satisfaction with the prosthesis (23.08%), postoperative drug use (15.38%), and outcomes related to well-being during surgery, treatment satisfaction, oral health satisfaction, psychosocial impact, daily life impairment and prosthesis functionality, among others (each 7.69%). Eighteen ClinROs were identified. Implant survival was reported in 38.46% of studies, prosthetic complications in 30.77%, and prosthetic survival in 23.08%. Peri-implant health parameters-bone level changes, probing depth, plaque and bleeding indices-were reported in 23.08%. Fewer studies assessed swelling (15.38%), surgical parameters (11.54%), articulation, and oromyofunctional behavior (5.6%). Assessment methods varied widely, limiting comparability. No clear pattern was observed regarding the timing of implant placement.

Conclusions: PROs and ClinROs exhibited significant heterogeneity in domains, methods, and reporting. Harmonizing outcome selection and establishing a core outcome set are needed to enhance comparability and reliability.

Objectives: To identify patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs) and patient-reported outcome measures (PROMs) in studies evaluating the rehabilitation of the edentulous maxilla with implant-supported fixed prosthesis using short and/or standard-length and/or zygomatic implants.

Materials and methods: A systematic search was conducted in MEDLINE/PubMed, EMBASE, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, and National Clinical Trial Register for articles published between January 1, 2014, and March 24, 2024. Studies reporting both PROMs and ClinROs related to implant therapy in patients with fully edentulous maxillae were eligible for inclusion. Study characteristics, PROMs, and ClinROs were extracted from each article. Study quality was appraised using Cochrane's Risk of Bias 2 tool, Newcastle-Ottawa Scale, or the Joanna Briggs Institute Critical Appraisal Tool according to the study design.

Results: The electronic search identified 1981 titles after removing duplicates. Fourteen publications, reporting both ClinROs and PROMs based on 12 studies (14 publications). These studies evaluated a total of 575 participants and 3367 implants. Eight publications focused exclusively on one type of implant design: seven evaluated standard-length implants and one examined zygomatic implants. The remaining six publications assessed two implant types: four compared zygomatic and standard-length implants, while two compared short and standard-length implants. The most frequently used PROMs among the publications (n = 14) were Oral Health-Related Quality-of-Life using OHIP questionnaires (7/14) and patient satisfaction using unstandardized questionnaires (7/14). The most frequently reported objective ClinROs were complication (14/14), marginal bone loss (10/14) assessed using standardized periapical radiographs, implant mobility/stability/failure (7/14), and implant survival (4/14). Subjective ClinROs related to the clinician's perception were reported in only one study (1/14) and focused on swelling after treatment.

Conclusions: PROMs and objective ClinROs are often reported together in clinical trials involving short, standard-length or zygomatic implants for implant-supported fixed prostheses in edentulous maxillae. However, the frequent use of unstandardized questionnaires for PROMs hinders sound comparisons across studies. Subjective ClinROs based on clinician perception are rarely reported.