In Vivo Evaluation of the Accuracy of Immediate Screw-Retained Provisional Crowns Fabricated Using Digital Planning and Guided Surgery

NCT07315607 | Recruiting DMC

• 1 other identifier: 25/700-E
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the in vivo accuracy of a fully digital workflow for the immediate placement of a previously fabricated screw-retained provisional crown using digital planning and guided implant surgery. The study will be conducted in partially edentulous adult patients requiring the replacement of a single tooth with an immediately loaded dental implant. The main objective of the study is to assess the accuracy (trueness and precision) of the planned digital implant position and provisional restoration by comparing the virtually planned position with the actual clinical outcome after guided surgery. Emphasis will be placed on linear, angular, and rotational deviations at both the implant and provisional restoration levels. Participants will undergo a fully guided implant placement procedure with rotational control, followed by the immediate placement of a prefabricated screw-retained provisional crown designed during the digital planning phase. Postoperative intraoral scans will be obtained to register the final implant and restoration positions. The planned and achieved positions will be compared using three-dimensional analysis software to quantify deviations and determine whether the accuracy achieved remains within clinically acceptable limits.

Conditions

Partial Edentulism; Tooth Loss / Rehabilitation

Keywords

Immediate provisionalization; Screw-retained provisional crown; Guided implant surgery; Digital implant planning

Outcome Measures

Primary Outcomes (1)

• Accuracy of Implant and Provisional Crown Placement

  Accuracy will be assessed as the combination of trueness and precision by quantifying plan-to-actual deviations between the digitally planned and clinically achieved implant position and provisional crown position. Linear deviations at the coronal and apical implant levels, angular deviation of the implant axis, and linear and angular deviations of the provisional restoration will be calculated using three-dimensional analysis software.

  Immediate postoperative period

Study Arms (1)

Fully Guided Implant Surgery With Immediate Prefabricated Provisional Crown

EXPERIMENTAL

Participants will undergo a fully guided implant placement procedure with rotational control, followed by the immediate placement of a previously fabricated screw-retained provisional crown designed during the digital planning phase.

Procedure: Fully Guided Implant Placement and Immediate Provisionalization

Interventions

Fully Guided Implant Placement and Immediate Provisionalization PROCEDURE

Fully guided implant placement using a digitally designed surgical guide with rotational control, followed by immediate placement of a prefabricated screw-retained provisional crown based on the virtual treatment plan.

Fully Guided Implant Surgery With Immediate Prefabricated Provisional Crown

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Partially edentulous patients requiring replacement of a single tooth with an immediately loaded dental implant.
• Patients classified as ASA I or ASA II according to the American Society of Anesthesiologists physical status classification.
• Patients with clinical conditions allowing immediate implant placement with a minimum primary stability of ≥25 Ncm.
• Ability to understand the study procedures and provide written informed consent.
• Willingness to comply with the study protocol and attend required clinical visits.

You may not qualify if:

• Patients classified as ASA III or ASA IV, or with uncontrolled systemic conditions that may interfere with study participation.
• Presence of psychiatric or cognitive disorders that may compromise informed consent or protocol compliance.
• Inability to comply with the visit schedule or required evaluations.
• Any other condition that, in the investigator's judgment, could compromise patient safety, protocol adherence, or data validity.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Complutense University of Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (19)

• Adams CR, Ammoun R, Deeb GR, Bencharit S. Influence of Metal Guide Sleeves on the Accuracy and Precision of Dental Implant Placement Using Guided Implant Surgery: An In Vitro Study. J Prosthodont. 2023 Jan;32(1):62-70. doi: 10.1111/jopr.13503. Epub 2022 Mar 22.

  PMID: 35257456 BACKGROUND

• Ballesteros J, Vasquez-Ramos S, Revilla-Leon M, Gomez-Polo M. Immediate placement of a previously manufactured interim screw-retained implant-supported crown by using the implant position determined in the guided implant planning. J Prosthet Dent. 2025 Oct;134(4):908-913. doi: 10.1016/j.prosdent.2025.07.009. Epub 2025 Jul 30.

  PMID: 40744851 BACKGROUND

• Yeager B, Cakmak G, Zheng F, Johnston WM, Yilmaz B. Error analysis of stages involved in CBCT-guided implant placement with surgical guides when different printing technologies are used. J Prosthet Dent. 2024 Nov;132(5):995-1004. doi: 10.1016/j.prosdent.2022.11.018. Epub 2023 Jan 21.

  PMID: 36690552 BACKGROUND

• Younis H, Lv C, Xu B, Zhou H, Du L, Liao L, Zhao N, Long W, Elayah SA, Chang X, He L. Accuracy of dynamic navigation compared to static surgical guides and the freehand approach in implant placement: a prospective clinical study. Head Face Med. 2024 May 14;20(1):30. doi: 10.1186/s13005-024-00433-1.

  PMID: 38745297 BACKGROUND

• Espona J, Roig E, Ali A, Roig M. Immediately loaded interim complete-arch implant-supported fixed dental prostheses fabricated with a completely digital workflow: A clinical technique. J Prosthet Dent. 2020 Oct;124(4):423-427. doi: 10.1016/j.prosdent.2019.08.008. Epub 2019 Dec 18.

  PMID: 31862143 BACKGROUND

• Hernandez-Margarit P, Palacios-Banuelos R, Roig M, Altuna P, Blasi A. Digital workflow for designing an interim implant-supported restoration with an optimal emergence profile in an open-source software program. J Prosthet Dent. 2024 Nov;132(5):857-862. doi: 10.1016/j.prosdent.2022.10.013. Epub 2022 Dec 6.

  PMID: 36494239 BACKGROUND

• Shah NP, Khanna A, Pai AR, Sheth VH, Raut SR. An evaluation of virtually planned and 3D-printed stereolithographic surgical guides from CBCT and digital scans: An in vitro study. J Prosthet Dent. 2022 Sep;128(3):436-442. doi: 10.1016/j.prosdent.2020.12.035. Epub 2021 Feb 12.

  PMID: 33583616 BACKGROUND

• Chen Z, Li J, Ceolin Meneghetti P, Galli M, Mendonca G, Wang HL. Does guided level (fully or partially) influence implant placement accuracy at post-extraction sockets and healed sites? An in vitro study. Clin Oral Investig. 2022 Aug;26(8):5449-5458. doi: 10.1007/s00784-022-04512-y. Epub 2022 May 2.

  PMID: 35499656 BACKGROUND

• Werny JG, Frank K, Fan S, Sagheb K, Al-Nawas B, Narh CT, Schiegnitz E. Freehand vs. computer-aided implant surgery: a systematic review and meta-analysis-part 1: accuracy of planned and placed implant position. Int J Implant Dent. 2025 May 2;11(1):35. doi: 10.1186/s40729-025-00622-w.

  PMID: 40314873 BACKGROUND

• Putra RH, Yoda N, Astuti ER, Sasaki K. The accuracy of implant placement with computer-guided surgery in partially edentulous patients and possible influencing factors: A systematic review and meta-analysis. J Prosthodont Res. 2022 Jan 11;66(1):29-39. doi: 10.2186/jpr.JPR_D_20_00184. Epub 2021 Jan 26.

  PMID: 33504723 BACKGROUND

• Khaohoen A, Powcharoen W, Sornsuwan T, Chaijareenont P, Rungsiyakull C, Rungsiyakull P. Accuracy of implant placement with computer-aided static, dynamic, and robot-assisted surgery: a systematic review and meta-analysis of clinical trials. BMC Oral Health. 2024 Mar 21;24(1):359. doi: 10.1186/s12903-024-04033-y.

  PMID: 38509530 BACKGROUND

• Lo Russo L, Ercoli C, Guida L, Merli M, Laino L. Surgical guides for dental implants: Measurement of the accuracy using a freeware metrology software program. J Prosthodont Res. 2023 Apr 12;67(2):300-304. doi: 10.2186/jpr.JPR_D_22_00069. Epub 2022 Aug 11.

  PMID: 35965064 BACKGROUND

• Gomez-Polo M, Ballesteros J, Padilla PP, Pulido PP, Revilla-Leon M, Ortega R. Merging intraoral scans and CBCT: a novel technique for improving the accuracy of 3D digital models for implant-supported complete-arch fixed dental prostheses. Int J Comput Dent. 2021 Jun 4;24(2):117-123.

  PMID: 34085497 BACKGROUND

• Derksen W, Wismeijer D, Flugge T, Hassan B, Tahmaseb A. The accuracy of computer-guided implant surgery with tooth-supported, digitally designed drill guides based on CBCT and intraoral scanning. A prospective cohort study. Clin Oral Implants Res. 2019 Oct;30(10):1005-1015. doi: 10.1111/clr.13514. Epub 2019 Sep 9.

  PMID: 31330566 BACKGROUND

• Kernen F, Kramer J, Wanner L, Wismeijer D, Nelson K, Flugge T. A review of virtual planning software for guided implant surgery - data import and visualization, drill guide design and manufacturing. BMC Oral Health. 2020 Sep 10;20(1):251. doi: 10.1186/s12903-020-01208-1.

  PMID: 32912273 BACKGROUND

• Shi Y, Wang J, Ma C, Shen J, Dong X, Lin D. A systematic review of the accuracy of digital surgical guides for dental implantation. Int J Implant Dent. 2023 Oct 25;9(1):38. doi: 10.1186/s40729-023-00507-w.

  PMID: 37875645 BACKGROUND

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  PMID: 24083034 BACKGROUND

• Chackartchi T, Romanos GE, Parkanyi L, Schwarz F, Sculean A. Reducing errors in guided implant surgery to optimize treatment outcomes. Periodontol 2000. 2022 Feb;88(1):64-72. doi: 10.1111/prd.12411.

  PMID: 35103317 BACKGROUND

• Nulty A. A literature review on prosthetically designed guided implant placement and the factors influencing dental implant success. Br Dent J. 2024 Feb;236(3):169-180. doi: 10.1038/s41415-024-7050-3. Epub 2024 Feb 9.

  PMID: 38332076 BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Miguel A Gómez Polo, DDS, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

• Juan Ballesteros- Martinez, DDs, MSc

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel A Gómez Polo ; DDS, PhD, DDS, PhD

CONTACT

+34659390001; mgomezpo@ucm.es

Solange J Vasquez Ramos, DDS, MSc

CONTACT

solvasqu@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of conservative dentistry and prosthodontics

Model Details: Participants will undergo a single fully guided implant placement procedure, and outcomes will be evaluated by comparing digitally planned and clinically achieved positions within the same individual.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)