Cement Excess at Single Implant Crowns Malmö/Lund

NCT04015427 | Completed DMC

• 1 other identifier: 2018-414
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract Aim: The primary aim of this study is to test whether or not cement residues in the submucosal environment of implants lead to a change in the microbiota and induce inflammation of the periimplant tissues. Material and Methods: 24 patients in need of a single tooth replacement will be enrolled in this cross-over controlled clinical study. All patients will receive a two-piece dental implant, which will be restored with both a cemented and a screw-retained single crown. At the time of impression taking, patients will be randomized into two groups. Patients in group A will receive a screw-retained crown. Every 8 weeks microbiological samples using sterile paper points will be collected and analyzed for bacterial content by real-time PCR. Additionally, two host markers (MMP8, IL-1ß) will be determined by ELISA. Following this first period of 16 weeks, the screw-retained crown will be replaced by a new intraorally cemented crown. Cement removal will be preformed according to best clinical procedure. These crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period. In group B the crowns will be incorporated in a reverse pattern. During the first 16 weeks any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A. After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.

Conditions

Gingivitis and Periodontal Diseases; Tooth Loss

Keywords

cement; dental; implant; implant prosthodontics

Outcome Measures

Primary Outcomes (1)

• Analysis of microbiological parameters

  Change relative percentage of gram-negative microorganisms

  Change BL to 16 weeks post-restoration

Secondary Outcomes (9)

• Histomorphometric analysis

  32 weeks after BL

• Immunohistologic analysis - putative periodontal pathogens

  32 weeks after BL

• Immunohistologic analysis - MMP8

  32 weeks after BL

• Immunohistologic analysis - IL1ß

  32 weeks after BL

• Analysis of inflammation markers on RNA-basis - (IL-4, IL-3, IL-1alfa, IL-1beta)

  32 weeks after BL

Other Outcomes (3)

• Determination of additional inflammatory markers - MMP8

  4 times 8 weeks

• Determination of additional inflammatory markers - IL-1ß

  4 times 8 weeks

• Radiological outcomes

  12 weeks pre-BL, BL and 1year post-BL

Study Arms (2)

screw-retained

ACTIVE COMPARATOR

Patients in group A will receive a screw-retained implant crown. Following this first period of 16 weeks, the screw-retained implant crown will be replaced by a new intraorally cemented implant crown. Cement removal will be preformed according to best clinical procedure. These implant crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the implant crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained implant crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period.

Device: implant crown

cement-retained

ACTIVE COMPARATOR

In group B the implant crowns will be incorporated in a reverse pattern. During the first 16 weeks a cemented implant crown will be inserted and any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single implant crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A.

Device: implant crown

Interventions

implant crown DEVICE

After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.

cement-retained; screw-retained

Eligibility Criteria

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

You may qualify if:

• \- patient older than 18 years
• systemically healthy subject
• periodontally healthy individuals
• absence of peri-implantitis
• no bone loss
• good oral hygiene (PCR ≤ 20%)
• healthy periodontal tissues (BoP≤ 20%)
• patients with a single tooth gap in the posterior area of either jaw (premolars and molars)
• at least 8mm in mandible; at least 6mm in maxilla (summers technique)

You may not qualify if:

• \- ongoing periodontal disease
• bruxism
• unwilling to comply with study procedures
• heavy smokers (≥10 cig/d)
• ongoing periodontitis/implantitis

Sponsors & Collaborators

• University of Zurich: lead
• Folktandvården Skåne AB: collaborator
• Göteborg University: collaborator
• Dentsply Sirona Implants and Consumables: collaborator

Study Sites (1)

Folktandvården Skåne

Lund, Skåne County, Sweden

Location

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases; Tooth Loss

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: July 11, 2019
• Study Start: June 27, 2018
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: mid 2020
• Access Criteria: login provided by the study monitor (UZH)

Locations

SE (1)