NCT04015427

Cement Excess at Single Implant Crowns Malmö/Lund

Completed NA Last updated 14 June 2022

What this trial tests

NA trial testing implant crown in Gingivitis and Periodontal Diseases in 24 participants. Completed in 30 April 2022.

Timeline

27 June 2018

Primary endpoint
30 April 2022

30 April 2022

Quick facts

Lead sponsor	University of Zurich
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	27 June 2018
Primary completion	30 April 2022
Estimated completion	30 April 2022
Sites	1 location across Sweden

Drugs / interventions tested

• implant crown

Conditions studied

• Gingivitis and Periodontal Diseases — all drugs for Gingivitis and Periodontal Diseases →
• Tooth Loss — all drugs for Tooth Loss →

Sponsor

University of Zurich

Who can join

18 and older, any sex, with Gingivitis and Periodontal Diseases or Tooth Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.