The Impact of Peri-implant Soft Tissue Properties on Patient-reported and Clinically Assessed Outcomes

NCT03396536 | Completed

• 1 other identifier: 11003
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate patient discomfort while performing oral hygiene (OH) around implants with and without keratinized mucosa (KM) and assess peri-implant soft tissue esthetic satisfaction and other clinical parameters at the 3- and 6-month follow-up visits. Group 1 will be implants with KM and Group 2 implants without KM. The hypotheses underlying this proposal are (1) that dental implants surrounded by KM will have better patient-reported outcomes regarding discomfort during brushing compared with those that lack KM; (2) that dental implants with KM will show more favorable clinical outcomes (plaque index, bleeding on probing, pocket depth and peri-implant recession) compared with those without KM and (3) that dental implants with KM will have higher patient peri-implant tissue esthetic satisfaction compared with those without KM.

Conditions

Keratinized Mucosa

Keywords

implant; oral hygiene; discomfort

Outcome Measures

Primary Outcomes (2)

• Patient Discomfort

  This will be a prospective clinical study to evaluate patient discomfort while performing oral hygiene (OH) around implants with and without KM and assess peri-implant soft tissue esthetic evaluation and other clinical parameters at the 3- and 6-month follow-up visits. The primary outcome will be discomfort during brushing at implant site.

  Change in patient discomfort at 3 months

• Patient Discomfort

  This will be a prospective clinical study to evaluate patient discomfort while performing oral hygiene (OH) around implants with and without KM and assess peri-implant soft tissue esthetic evaluation and other clinical parameters at the 3- and 6-month follow-up visits. The primary outcome will be discomfort during brushing at implant site.

  Change in patient discomfort at 6 months

Study Arms (2)

Group 1

Group 1 will be implants with keratinized mucosa (KM).

Other: Evaluation of KM

Group 2

Group 2 implants without keratinized mucosa (KM). Alveolar mucosa (AM) directly present around the implant.

Other: Evaluation of KM

Interventions

Evaluation of KM OTHER

KM will be evaluated. The alveolar mucosa will be stained with Lugol's solution, by means of a cotton swab. A cotton roll will be soaked in the solution and gently applied on the mucosa around the implant. Since Lugol's solution is selective to the glycogen present in AM, the muco-gingival junction as the borderline between the blue-stained alveolar mucosa and KM can be easily identified. A manual periodontal probe with 1 mm markings will measure the distance from the peri-implant margin and the muco-gingival junction. Mucosal thickness (MT) will be measured after topical application of the anesthetics. MT will be evaluated inserting a 27G needle with a rubber stop 1 mm below the peri-implant mucosal margin at the mid-buccal aspect, until the abutment is engaged. The needle will be removed and the distance between the rubber stop and the point of the needle will be measured with a manual periodontal probe.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A sample size calculation was conducted using nQuery Advisor (Version 7.0). Assuming that 37.5% in the non-KM group (Group 2) have high discomfort and 2% in the KM Group (Group 1) have high discomfort, a Type I error rate of 5%/2 = 2.5% per test and a power of 80% are obtained as long as there are n=23 subjects with a KM implant and n=23 subjects with a non-KM implant. To account for possible dropout, up to n=28 subjects with each type of peri-implant mucosa group (for a total of up to 56 subjects) will be included in the study. Up to 80 subjects will be enrolled in order to have 56 complete the study.

You may qualify if:

• Patients 18 years of age or older
• Patients treatment planned for second stage implant surgery (having already had stage one completed
• Partially or fully edentulous patients that have a single implant or have multiple implants that are non-adjacent
• Patients that have implant(s) that will be restored with fixed cement- or screw-retained restoration(s)

You may not qualify if:

• Unwilling to sign informed consent form
• Non-English speaking subjects
• Pregnant women (self-reported)
• Heavy smokers (10 cigarettes/day)
• Known allergy to iodine and/or potassium iodide (ingredients of Lugol's solution)

Sponsors & Collaborators

• Tufts University: lead

Study Officials

• Hans-Peter Weber

  TUSDM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: January 11, 2018
• Study Start: January 15, 2014
• Primary Completion: June 9, 2015
• Study Completion: June 9, 2015
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share