NCT04135222

Brief Summary

The use of CBCT/CAD and PDIP technology makes it possible to determine the gingival and the periodontal phenotype, and it can be useful in establishing treatment plan in which it is required to carry out radiological diagnostics. Assessment of the periodontal and the gingival phenotype in a patient using the method based on CW/CL ratio is unreliable. Determining it for each dento-gingival unit is the appropriate method. Positive correlation between FGT, WKT and AC-GM distance confirms the purpose of measuring these parameters for evaluation of the gingival phenotype and additional TLPAC2 for the periodontal phenotype.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

September 19, 2019

Last Update Submit

October 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • determination the gingival and the periodontal phenotype

    The use of CBCT, CAD and PDIP technology makes it possible to determine the gingival and the periodontal phenotype, and it can be useful in establishing treatment plan in which it is required to carry out radiological diagnostics. Assessment of the periodontal and the gingival phenotype in a patient using the method based on CW/CL (%) ratio is unreliable. Determining it for each dento-gingival unit is the appropriate method. Positive correlation between FGT (mm), WKT(mm) and AC-GM (mm) distance confirms the purpose of measuring these parameters for evaluation of the gingival phenotype and additional TLPAC2 for the periodontal phenotype.

    October 2018 to July 2019

Interventions

Measurements were performed at upper canines and incisors in thirty periodontally healthy patients. The CBCT/CAD technology along with the PDIP software were used to measure crestal (CGT in mm ), supracrestal (SGT in mm) and free gingival thickness (FGT in mm ) as well as alveolar crest-gingival margin (AC-GM) and cemento-enamel junction (AC-CEJ) distance and the TLPAC localized 2, 4 and 8mm apically than the edge of the AC. Width of keratinized tissue (WKT) were measured using a periodontal probe. For each patient, the periodontal phenotype was evaluated on the basis of coronal width/length (CW/CL in percentages) ratio of both upper central incisors. For each tooth, the gingival phenotype was assessed on the basis of the GT measurement( in mm).

Eligibility Criteria

Age24 Years - 54 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details16 male 14 female
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

male 16 female 14

You may qualify if:

  • lack of general diseases
  • good hygiene of oral cavity
  • healthy periodontium - API ratio\<15%, BOP\<10%
  • no loss of clinical attachment in the examined sites (CAL=0)
  • no use of drugs that could influence the structure of the periodontal tissues
  • no addictions, especially nicotinism
  • no use of mobile prosthetic restorations and orthodontic appliances
  • no contraindications for X-ray examinations

You may not qualify if:

  • general diseases
  • bad hygiene of oral cavity
  • non healthy periodontium - API ratio\>15%, BOP\>10%
  • loss of clinical attachment in the examined sites (CAL\>1)
  • use of drugs that could influence the structure of the periodontal tissues
  • addictions, especially nicotinism
  • use of mobile prosthetic restorations and orthodontic appliances
  • contraindications for X-ray examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical University

Wroclaw, 52129, Poland

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • wojciech bednarz, prof

    Medical Uniwersity Wroclaw

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

October 22, 2019

Study Start

October 11, 2018

Primary Completion

May 13, 2019

Study Completion

July 7, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations