Immediate Loading a Histological Study

NCT03714139 | Completed DMC

• 1 other identifier: dental implants
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Twelve participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments. One site will be used as a test and one as a control where experimental mini-implants will be installed. Reconstructive surgical procedures will be applied at the biopsy sites.

Conditions

Edentulous Alveolar Ridge

Keywords

Dental Implants; bone healing; clinical trial; histology

Outcome Measures

Primary Outcomes (1)

• bone to implant contact

  The linear distances between IS and B (IS-B) and CM and X (CM-X) were measured parallel to the long axis of the implant at both sides of the implant at a magnification of x100. Moreover, the amount of new bone, old bone, total bone (new + old bone = BIC%

  2 months

Secondary Outcomes (1)

• Bone density

  2 months

Study Arms (2)

Immediate implant Loading

EXPERIMENTAL

Immediate loading is defined as the placement of the implant and immediate prosthetic restoration

Procedure: immediate loading; Procedure: non implant loading

non implant loading

NO INTERVENTION

there is not immediate prosthetic restoration

Interventions

immediate loading PROCEDURE

The participants will be assigned to immediate or delayed functional loading groups. In each participant, edentulous areas with adequate thickness of the alveolar bone crest will be identified and at least two sites will be identified for implant installation. All implant recipient sites will be sub-prepared to allow good stability of the implants. Experimental mini-implants (Sweden \& Martina, Due Carrare, Padova, Italy), 3.5 mm in diameter and with an intraosseous portion of 4 mm in length will be installed. Immediate loading group - A prosthetic component will be applied over the trial implants. Impressions will be taken and a crown / bridge will be provided to patients in one day.

Also known as: implant surgery, prosthesis

Immediate implant Loading

non implant loading PROCEDURE

Control implants will receive a healing screw and will remain unloaded

Also known as: control site

Immediate implant Loading

Eligibility Criteria

• Age: 25 Years - 70 Years
• Gender Eligibility Details: patients with edentulous spaces
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants (≥25 years of age) with the need of at least two implants to replace teeth of the jaw will be included.
• Natural antagonist teeth have to be present both at test and control sites to guarantee occlusal contacts

You may not qualify if:

• untreated rampant caries or uncontrolled periodontal disease of the remaining teeth
• diabetes not controlled diabetes or any other systemic or local disease that could compromise postoperative healing and / or osseointegration
• need for systemic corticosteroids or any other medication that could compromise postoperative healing and / or osseointegration
• inability or unwillingness to return to follow-up not likely to be able to comply with the study procedures according to the judgment of the investigators
• pregnancy

Sponsors & Collaborators

• ARDEC Academy: lead

Study Sites (1)

Colombia

Cartagena, Cartagena, 5710, Colombia

Location

Related Publications (7)

• Bousdras VA, Walboomers F, Jansen JA, Cunningham JL, Blunn G, Petrie A, Jaecques S, Naert IE, Sindet-Pedersen S, Goodship AE. Immediate functional loading of single-tooth TiO2 grit-blasted implant restoration. A controlled prospective study in a porcine model. Part II: Histology and histomorphometry. Clin Implant Dent Relat Res. 2007 Dec;9(4):207-16. doi: 10.1111/j.1708-8208.2007.00039.x.

  PMID: 18031442 BACKGROUND

• Calandriello R, Tomatis M, Vallone R, Rangert B, Gottlow J. Immediate occlusal loading of single lower molars using Branemark System Wide-Platform TiUnite implants: an interim report of a prospective open-ended clinical multicenter study. Clin Implant Dent Relat Res. 2003;5 Suppl 1:74-80. doi: 10.1111/j.1708-8208.2003.tb00018.x.

  PMID: 12691653 BACKGROUND

• Cecchinato D, Bressan EA, Toia M, Araujo MG, Liljenberg B, Lindhe J. Osseointegration in periodontitis susceptible individuals. Clin Oral Implants Res. 2012 Jan;23(1):1-4. doi: 10.1111/j.1600-0501.2011.02293.x. Epub 2011 Nov 1.

  PMID: 22092689 BACKGROUND

• Degidi M, Petrone G, Lezzi G, Piattelli A. Histologic evaluation of 2 human immediately loaded and 1 titanium implants inserted in the posterior mandible and submerged retrieved after 6 months. J Oral Implantol. 2003;29(5):223-9. doi: 10.1563/1548-1336(2003)0292.3.CO;2.

  PMID: 14620684 BACKGROUND

• Degidi M, Piattelli A, Shibli JA, Perrotti V, Iezzi G. Bone formation around immediately loaded and submerged dental implants with a modified sandblasted and acid-etched surface after 4 and 8 weeks: a human histologic and histomorphometric analysis. Int J Oral Maxillofac Implants. 2009 Sep-Oct;24(5):896-901.

  PMID: 19865630 BACKGROUND

• Degidi M, Scarano A, Petrone G, Piattelli A. Histologic analysis of clinically retrieved immediately loaded titanium implants: a report of 11 cases. Clin Implant Dent Relat Res. 2003;5(2):89-93. doi: 10.1111/j.1708-8208.2003.tb00189.x.

  PMID: 14536043 BACKGROUND

• Bosshardt DD, Salvi GE, Huynh-Ba G, Ivanovski S, Donos N, Lang NP. The role of bone debris in early healing adjacent to hydrophilic and hydrophobic implant surfaces in man. Clin Oral Implants Res. 2011 Apr;22(4):357-64. doi: 10.1111/j.1600-0501.2010.02107.x.

  PMID: 21561477 RESULT

MeSH Terms

Interventions

Immediate Dental Implant Loading; Prostheses and Implants

Intervention Hierarchy (Ancestors)

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

Study Officials

• Daniele Botticelli, PHd

  ARDEC Academy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One of the researchers , neither involved in the selection of the patients nor in the surgical and prosthetic treatment, will carry out electronically the randomization (randomization.com). Will be prepared sealed opaque envelopes and opened at the time of surgery.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Split mouth, At least one site will be used as a test and one as a control where experimental mini-implants will be installed.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: March 3, 2018
• Primary Completion: January 30, 2019
• Study Completion: February 28, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

CO (1)