Differences Between Two Type Implants in Post-extraction Alveolus

NCT05665231 | Completed DMC

• 1 other identifier: 080237
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

One of the challenges of current implantology involves the preservation or reduction of existing bone resorption, mainly in the buccal bone plate, after tooth loss, which becomes of special importance in the anterior region of the maxilla (aesthetic region). The study evaluates the macroscopic shape of neck implant influence in the results of immediate implants, in a population comprised of individuals from the clinic of the Faculty of Dental Medicine of the University of Porto in need of replacement of a single tooth. It is intended to evaluate the morphometric (direct measures and plaster models measurements), imaging, and photographic characteristics of the V3 implant in comparison with the C1 implant of Mis® by an evaluation period of 6 months when placing an immediate implant.

Conditions

Dental Implants, Single-Tooth

Keywords

dental implants; extraction socket; immediate placement; implant geometry

Outcome Measures

Primary Outcomes (12)

• A - Bone defect (clinical variables)

  At T0, the edentulous space to be rehabilitated will be characterized in terms of the morphometric level of the existing defect in the vestibular cortical, according to the classification by Caplanis N. in EDS-1 or EDS-2.

  T0

• B- Bacterial plaque index (O'Leary index)(clinical variables)

  At time T-1 and T4, the investigator will analyse the existing plaque on teeth adjacent to the surgical site using a dichotomous score (0 = no visible plaque at the soft tissue margin, 1 = visible plaque at the soft tissue margin). The result will be present in percentage (0% (better)-100%(worse)) and will describe the change between T-1 and T4, and compare the results between implants type.

  6 months

• C- Probing depth (clinical variables)

  At Time T-1 and T4, the investigators will analyse the probing depth of the teeth adjacent to the site to be treated at 6 points: mesiobuccal, vestibular, distobuccal, mesiopalatal, palatine, distopalatal. The recordings will be carried out with a CP 15 UNC, Hu-Friedy® Chicago, IL, EUA manual probe.The result will be present in millimeters. The change between T-1 and T4 is also going to be analysed and compare implants results.

  6 months

• D- Bleeding on probing (clinical variables)

  At time T-1 and T4, the investigators will analyse the bleeding on probing of the teeth adjacent to the site to be treated at 6 points: mesiobuccal, vestibular, distobuccal, mesiopalatal, palatine, distopalatal. The recordings of bleeding on probing will be carried out with a CP 15 UNC, Hu-Friedy® Chicago, IL, EUA manual probe.The result will be present in percentage (0% (better)-100%(worse)) and will describe the change between T-1 and T4 and compare between implants type.

  6 months

• E- Gingival phenotype (clinical variables)

  At time T-1, the identification of the gingival phenotype is performed by clinical inspection with a periodontal probe. The gingival phenotype will be classified as thin, moderate or thick. The investigators will compare implant results.

  T-1

• F- Implant insertion torque (Clinical variables)

  Recording of implant insertion torque, in Ncm during placement in T1, and compare implants results.

  T1

• G- Implant stabilization quotient (ISQ) (clinical variables)

  Determination of the implant stability coefficient at the time of implant placement (T1) and in the 2nd surgical phase (T3) using the Osstell® device (minimum 1; maximum 100; high stability when ≥70) and analysis of the change between T1 and T3 and different implants results.

  6 months

• Morphometric evaluation (clinical direct measurements)

  Compare Direct measurements (millimeters) at the different times intervention with periodontal probe or gauge and analyse the change between times and compare implant results. In T-1, T2 and T3c and T4 the investigators will evaluate interdental distance; BPD, cortical bone, papilla and volume, corresponding of measurements: a,b,c and r. In T0, the investigators will evaluate interdental distance; BPD, cortical, bone and global volume corresponding to measurements: a, b, c, d, e, q, r, s, t, and u). In T1 e T3, the investigators will evaluate interdental distance; BPD, cortical, bone and global volume, implant parameter corresponding to measurements: a, b, d, e, f, g, h, I, j, k, l, m, n, p, q, r and ISQ value.

  6 months

• Morphometric evaluation (plaster models measurements)

  Preparation of plaster models at times T-1 and T4 and the following measurements (millimeter) will be evaluated with the use of periodontal probe or gauge and will analyse the change between T-1 and T4 and compare implants results: 1. interdental distance 2. bucco-palatal distance (BPD) 3. presence of papilla r. global volume.

  6 months

• Imaging periapical X-ray evaluation (millimeter)

  The investigator will measure (millimeters, using the imaging software virtual ruler) the results of digital X-ray at times T-1, T1,T4 and analyse the variation and compare implants results. The measurements are: a. interdental distance; i. implant - cemento-enamel junction (CEJ) of adject teeth distance; l. distance from the implant position depth to the buccal bone crest; n. implant diameter; o. implant length.

  6 months

• Cone Beam Tomography (CBCT) evaluation (millimeter)

  The investigator will measure (millimeters, using the imaging software virtual ruler) the results of CBCT at times T-1 and T4, analyse the variation and compare implants results. The measurements are: 1. interdental distance; 2. bucco-palatal distance (BPD); d. buccal cortical distance; e. palatal cortical distance; f. mesial cortical distance; g. distal cortical distance; h. jumping distance; j. buccal cortical wall-implant distance; k. jumping distance space depth; l. distance from the implant position depth to the buccal bone crest; m. distance from the buccal cortex to the center of the implant; n. implant diameter; o. Implant length; q. global bone volume; r. global volume; s. alveolus buccal-palatal distance; t. alveolus mesial-distal distance; u. alveolus depth.

  6 months

• PES/WES index - Photography results

  The investigator will analyse the intraoral photographs to describe the Pes/Wes index, in time T-1 (initial) and T4 (final), and compare the PES/WES results between implants.The score will range on 0-10, the best score is ≥8.

  6 months

Secondary Outcomes (3)

• Osseointegration survival rate

  6 months

• Biological complication

  6 months

• Prosthetic complication

  6 months

Study Arms (2)

V3 Mis® implant

EXPERIMENTAL

Implant with coronal triangular neck

Other: A - Bone defect (clinical variables); Other: B- Bacterial plaque index (O'Leary index)(clinical variables); Other: C- Probing depth; Other: D- Bleeding on probing; Other: E- Gingival phenotype; Other: F- Implant insertion torque (Clinical variables); Other: G- Implant stabilization quotient (ISQ) (clinical variables); Other: Morphometric results (Direct measurements - millimeter); Other: Morphometric results (plaster models measurements - millimeter); Other: Imaging Results (X-ray) (millimeter); Other: Imaging Results (CBCT)(millimeter); Other: Photographic results PES/WES index

C1 MIS® implant

ACTIVE COMPARATOR

Implant with coronal cylindrical neck (regular)

Other: A - Bone defect (clinical variables); Other: B- Bacterial plaque index (O'Leary index)(clinical variables); Other: C- Probing depth; Other: D- Bleeding on probing; Other: E- Gingival phenotype; Other: F- Implant insertion torque (Clinical variables); Other: G- Implant stabilization quotient (ISQ) (clinical variables); Other: Morphometric results (Direct measurements - millimeter); Other: Morphometric results (plaster models measurements - millimeter); Other: Imaging Results (X-ray) (millimeter); Other: Imaging Results (CBCT)(millimeter); Other: Photographic results PES/WES index

Interventions

A - Bone defect (clinical variables) OTHER

At T0, the edentulous space to be rehabilitated will be characterized in terms of the morphometric level of the existing defect in the vestibular cortical, according to the classification by Caplanis N. in EDS-1 or EDS-2.

C1 MIS® implant; V3 Mis® implant

B- Bacterial plaque index (O'Leary index)(clinical variables) OTHER

At time T-1 and T4, the investigator will analyse the existing plaque on teeth adjacent to the surgical site using a dichotomous score (0 = no visible plaque at the soft tissue margin, 1 = visible plaque at the soft tissue margin). The result will be present in percentage (0% (better)-100%(worse)) and will describe the change between T-1 and T4, and compare the results between implants type.

C1 MIS® implant; V3 Mis® implant

C- Probing depth OTHER

At Time T-1 and T4, the investigators will analyse the probing depth of the teeth adjacent to the site to be treated at 6 points: mesiobuccal, vestibular, distobuccal, mesiopalatal, palatine, distopalatal. The recordings will be carried out with a CP 15 UNC, Hu-Friedy® Chicago, IL, EUA manual probe.The result will be present in millimeters. The change between T-1 and T4 is also going to be analysed and compare implants results.

C1 MIS® implant; V3 Mis® implant

D- Bleeding on probing OTHER

At time T-1 and T4, the investigators will analyse the bleeding on probing of the teeth adjacent to the site to be treated at 6 points: mesiobuccal, vestibular, distobuccal, mesiopalatal, palatine, distopalatal. The recordings of bleeding on probing will be carried out with a CP 15 UNC, Hu-Friedy® Chicago, IL, EUA manual probe.The result will be present in percentage (0% (better)-100%(worse)) and will describe the change between T-1 and T4 and compare between implants type.

C1 MIS® implant; V3 Mis® implant

E- Gingival phenotype OTHER

At time T-1, the identification of the gingival phenotype is performed by clinical inspection with a periodontal probe. The gingival phenotype will be classified as thin, moderate or thick. The investigators will compare implant results.

C1 MIS® implant; V3 Mis® implant

F- Implant insertion torque (Clinical variables) OTHER

Recording of implant insertion torque, in Ncm during placement in T1, and compare implants results.

C1 MIS® implant; V3 Mis® implant

G- Implant stabilization quotient (ISQ) (clinical variables) OTHER

Determination of the implant stability coefficient at the time of implant placement (T1) and in the 2nd surgical phase (T3) using the Osstell® device (minimum 1; maximum 100; high stability when ≥70) and analysis of the change between T1 and T3 and different implants results.

C1 MIS® implant; V3 Mis® implant

Morphometric results (Direct measurements - millimeter) OTHER

Compare Direct measurements (millimeters) at the different times intervention with periodontal probe or gauge and analyse the change between times and compare implant results. In T-1, T2 and T3c and T4 the investigators will evaluate interdental distance; BPD, cortical bone, papilla and volume, corresponding of measurements: a,b,c and r. In T0, the investigators will evaluate interdental distance; BPD, cortical, bone and global volume corresponding to measurements: a, b, c, d, e, q, r, s, t, and u). In T1 e T3, the investigators will evaluate interdental distance; BPD, cortical, bone and global volume, implant parameter corresponding to measurements: a, b, d, e, f, g, h, I, j, k, l, m, n, p, q, r and ISQ value.

C1 MIS® implant; V3 Mis® implant

Morphometric results (plaster models measurements - millimeter) OTHER

Preparation of plaster models at times T-1 and T4 and the following measurements (millimeter) will be evaluated with the use of periodontal probe or gauge and will analyse the change between T-1 and T4 and compare implants results: 1. interdental distance 2. bucco-palatal distance (BPD) 3. presence of papilla r. global volume.

C1 MIS® implant; V3 Mis® implant

Imaging Results (X-ray) (millimeter) OTHER

The investigator will measure (millimeters, using the imaging software virtual ruler) the results of digital X-ray at times T-1, T1,T4 and analyse the variation and compare implants results. The measurements are: a. interdental distance; i. implant - cemento-enamel junction (CEJ) of adject teeth distance; l. distance from the implant position depth to the buccal bone crest; n. implant diameter; o. implant length.

C1 MIS® implant; V3 Mis® implant

Imaging Results (CBCT)(millimeter) OTHER

The investigator will measure (millimeters, using the imaging software virtual ruler) the results of CBCT at times T-1 and T4, analyse the variation and compare implants results. The measurements are: 1. interdental distance; 2. bucco-palatal distance (BPD); d. buccal cortical distance; e. palatal cortical distance; f. mesial cortical distance; g. distal cortical distance; h. jumping distance; j. buccal cortical wall-implant distance; k. jumping distance space depth; l. distance from the implant position depth to the buccal bone crest; m. distance from the buccal cortex to the center of the implant; n. implant diameter; o. Implant length; q. global bone volume; r. global volume; s. alveolus buccal-palatal distance; t. alveolus mesial-distal distance; u. alveolus depth.

C1 MIS® implant; V3 Mis® implant

Photographic results PES/WES index OTHER

The investigator will analyse the intraoral photographs to describe the Pes/Wes index, in time T-1 (initial) and T4 (final), and compare the PES/WES results between implants.The score will range on 0-10, the best score is ≥8.

C1 MIS® implant; V3 Mis® implant

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 and over
• Patients with understanding and free decision-making for informed consent
• Patients who need rehabilitation of a tooth in the region of incisors, canines, or maxillary premolars
• Patients with EDS-1 or EDS-2 dental sockets, according to Caplanis N. classification.

You may not qualify if:

• Patients with systemic pathologies that contraindicate the surgical procedure;
• Prolonged Non-steroidal anti-inflammatory drugs (NSAIDs);
• Bisphosphonate therapy;
• Lack of opposing teeth on implant site;
• Lack of adjacent teeth on implant site;
• Dental-sockets with total loss of one of the cortical;
• Untreated periodontal pathology;
• Pathology or circumstance that prevents patients from attending routine check-ups;
• Patients who smoke more than 10 cigarettes/day. Smokers are advised to reduce or stop smoking.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculty of Dental Medicine, Porto University

Porto, 4200-393, Portugal

Location

Related Publications (8)

• Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.

  PMID: 28000278 RESULT

• Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Tissue modeling following implant placement in fresh extraction sockets. Clin Oral Implants Res. 2006 Dec;17(6):615-24. doi: 10.1111/j.1600-0501.2006.01317.x.

  PMID: 17092218 RESULT

• Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167.

  PMID: 28000281 RESULT

• Caplanis N, Lozada JL, Kan JY. Extraction defect assessment, classification, and management. J Calif Dent Assoc. 2005 Nov;33(11):853-63.

  PMID: 16463907 RESULT

• Perez-Albacete Martinez MA, Perez-Albacete Martinez C, Mate Sanchez De Val JE, Ramos Oltra ML, Fernandez Dominguez M, Calvo Guirado JL. Evaluation of a New Dental Implant Cervical Design in Comparison with a Conventional Design in an Experimental American Foxhound Model. Materials (Basel). 2018 Mar 21;11(4):462. doi: 10.3390/ma11040462.

  PMID: 29561788 RESULT

• Li Manni L, Lecloux G, Rompen E, Aouini W, Shapira L, Lambert F. Clinical and radiographic assessment of circular versus triangular cross-section neck Implants in the posterior maxilla: A 1-year randomized controlled trial. Clin Oral Implants Res. 2020 Sep;31(9):814-824. doi: 10.1111/clr.13624. Epub 2020 Jun 29.

  PMID: 32496624 RESULT

• Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12.

  PMID: 24621203 RESULT

• Belser UC, Grutter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435.

  PMID: 19228100 RESULT

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Ricardo Faria Almeida, PhD

  Faculdade de Medicina Dentaria da Universidade do Porto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The envelopes were prepared prior to the start of the clinical study, mixed and stored. before each surgery, an envelope was randomly taken for the preparation of the surgery
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The sample consists of 20 clinical cases of unitary tooth loss in the region of the incisors, canines, and maxillary premolars of patients from the clinic of the Faculty of Dental Medicine of the University of Porto. Clinical cases were randomly grouped into 2 implant groups (triangular shape - implant V3 form Mis® and cylindrical shape - implant C1 from Mis®) by a closed envelope allocation (triangular shape implant: 10 clinical cases; cylindrical shape: 10 clinical cases). Three consecutive measurements were performed for each parameter, using their average for statistical analysis. The envelopes were prepared prior to the start of the clinical study, mixed and stored. before each surgery, an envelope was randomly taken for the preparation of the surgery.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 27, 2022
• Study Start: June 1, 2017
• Primary Completion: January 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)