Study of Hard and Soft Tissue Behavior Around Abutments on Implants.

NCT05924451 | Completed DMC

• 1 other identifier: REST-ECL-2020-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To compare the loss of peri-implant tissue by means of radiographic and digital analysis of a zirconia prosthesis placed immediately and delay loading. Materials and methods: 60 consecutive patients with the need for a full-arch rehabilitation were selected and divided randomly into two groups: Group A: Conventional dental extraction, placement of 6 to 8 implants. Placement of the multi-unit prosthetic attachment and finally in the same week the placement of the definitive monolithic zirconia prosthesis on implants. Group B: Conventional dental extraction, placement of 6 to 8 implants. Placement of prosthetic and provisional attachment. After 3 months, place the definitive prosthesis. Assess volumetric changes using radiographic and optical scan techniques. The number of implant failures, prosthetic incidents and bone loss around the implants will be evaluated. The data will be evaluated 3, 6, and 12 months after the operation.

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (4)

• Overall result of final prosthesis

  The final prosthesis will be judged by the patient. A 10 cm Visual analogue scale (VAS) is used. 0 (unacceptable) is placed in left end, and 10 (perfect) is placed in the right end.

  One day

• Gingival index

  The Gingival Index will be assessed according to a modified version of Loe and Silness and scored as: 0 = normal mucosa, 1 = bleeding with superficial probing, or 2 = spontaneous bleeding.

  One day

• Patient satisfaction

  Patient satisfaction will be evaluated separately in function and esthetics using a scale with ratings of 0 to 10 where 10 = fully satisfied and 0 = not satisfied.

  One day

• Bone-implant contact

  A single independent calibrated examiner will made linear measurements on each periapical radiograph from the most mesial and distal point of the implant platform to the crestal bone.

  One day

Study Arms (2)

Early loading

ACTIVE COMPARATOR

The implants will be restored with a PMMA (polymethyl methacrylate) prosthesis in normal occlusion.

Behavioral: Immediate Loading

Immediate loading

EXPERIMENTAL

The implants will be restored with a permanent prosthesis (monolithic zirconia) placed on the implants as an immediate loading.

Behavioral: Immediate Loading

Interventions

Immediate Loading BEHAVIORAL

Clinical and radiographic examination of the periimplant soft and hard tissue will be analysed by using gingival index, plaque index, and pocket depth immediately post operative.

Early loading; Immediate loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Physically and mentally capable of completing the 1-year follow-up
• With a stable occlusal relationship with or without opposing dentition
• Are willing and able to comply with study-related procedures
• Have good oral hygiene
• Present good quality and quantity of bone for implant placement.
• Must be American Society of Anesthesiologists (ASA) physical status of I or II, periodontal stable, and can enroll in a periodontal maintenance program.

You may not qualify if:

• Health conditions that do not permit surgical or restorative procedures (including anesthesia).
• Disorder in the planned implant area (eg, previous tumors, chronic bone disease, or previous irradiation).
• History of alcohol or drug abuse
• Smoke more than one pack of cigarettes per day (\> 20 cigarettes or equivalent)
• Uncontrolled diabetes
• Bisphosphonate therapy
• Pathologic occlusion, (eg, severe bruxism or other parafunctional habits)
• Lack opposing dentition or has unstable occlusion
• Needs of bone augmentations or sinus lift treatments
• Ongoing infections or endodontic or periodontal problems in opposing teeth or implants
• Poor oral hygiene
• Allergic or adverse reactions to the restorative material.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Clinica Universitaria d'Odontologia

Sant Cugat Del Vallés, Barcelona, 08195, Spain

Location

Related Publications (4)

• Gomez-Polo M, Ballesteros J, Perales-Padilla P, Perales-Pulido P, Gomez-Polo C, Ortega R. Guided implant scanning: A procedure for improving the accuracy of implant-supported complete-arch fixed dental prostheses. J Prosthet Dent. 2020 Aug;124(2):135-139. doi: 10.1016/j.prosdent.2019.09.022. Epub 2019 Nov 21.

  PMID: 31761274 BACKGROUND

• Suarez-Feito JM, Sicilia A, Angulo J, Banerji S, Cuesta I, Millar B. Clinical performance of provisional screw-retained metal-free acrylic restorations in an immediate loading implant protocol: a 242 consecutive patients' report. Clin Oral Implants Res. 2010 Dec;21(12):1360-9. doi: 10.1111/j.1600-0501.2010.01956.x.

  PMID: 20637035 BACKGROUND

• Meneghetti P, Moura GF, Tavelli L, Li J, Siqueira R, Wang HL, Mendonca G. A fully digital approach for implant fixed complete dentures: A case report. J Esthet Restor Dent. 2021 Dec;33(8):1070-1076. doi: 10.1111/jerd.12798. Epub 2021 Jul 2.

  PMID: 34213055 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

MeSH Terms

Conditions

Jaw, Edentulous

Interventions

Immediate Dental Implant Loading

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• MIGUEL ROIG CAYON, MD DDS PHD

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The clinician performs the treatment of implant placement and prosthesis and the investigator analyzes the hard and soft tissue changes recorded over time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Restorative Dentistry

Model Details: Patients will be randomly assigned into two main groups according to the time of implant loading, in group A, an early loading will be applied with a PMMA and in group B, an immediate functional loading protocol will be applied with the zirconia prosthesis over the implants.

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 29, 2023
• Study Start: September 14, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)