Accuracy of Assessing the Gingival Biotype in Upper Anterior in Adult Patients, Using Different Methods.

NCT04640506 | Unknown DMC

• 1 other identifier: PER -3-3-1
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a Diagnostic accuracy study that determining the accuracy of assessing the gingival biotype and some other anatomic parameters,including (crown width / crown length ratio, attached gingival width, labial bone thickness and papilla volume) by different methods :1- probe transparency, 2-transgingival probing, 3-cone beam computed tomography, 4-intraoral digital scanning, 5-extraoral digital scanning

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• gingival biotype assessment by different methods.

  will be assess by different methods measurement 1. probe transparency (PT) 2. transgingival probing (TP) , 3-cone-beam computed tomography (CBCT) 4-intraoral digital scanning (IDS) 5-extraoral digital scanning (EDS) I will be measured according to De Rouck et al. : * less than 1 mm thin-scalloped biotype'' (cluster A1): ''slender teeth, a narrow zone of keratinized tissue and a highly scalloped gingival margin * more than 1 mm 'thick-flat biotype'' (cluster B): A clear thick gingiva was found in about two-thirds quadratic teeth, a broad zone of keratinized tissue and a flat gingival margin * more than 1 mm (cluster A2): a clear thick gingiva with slender teeth, a narrow zone of keratinized tissue and a high gingival scallop

  the outcome measure will be assessed and for which data will be reported up to 24 weeks"

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adult Egyptian dental patients receiving esthetic rehabilitation treatment (implant placement, restorative treatments, periodontal therapy, and root cov¬erage) on anterior maxilla at faculty of Dentistry, Cairo University.

You may qualify if:

• Male and female Patients whose age is between 18 to 40 years old.
• Health teeth only will be included.
• Patients who already need esthetic rehabilitation treatment (implant placement, restorative treatments, periodontal therapy, and root coverage) on anterior maxilla and this treatment needs to investigate the gingival biotype.
• An un-inflamed periodontal condition with a periodontal probing depth of no more than 3 mm, a bleeding index of \< 2, and no gingival recession on maxillary anterior teeth.
• Provide informed consent.

You may not qualify if:

• Pregnant or lactating females.
• Restoration or crowns in the maxillary anterior dentition.
• Malocclusion.
• Use of any medication affecting the soft tissue.
• Cigarette smoking.
• Individuals with chronic systemic diseases such as diabetes, endocrine and haematological pathologies.
• Patients having problem in opening their mouth or undergoing inter-maxillary fixation where oral examination will not be possible.
• Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
• Patients with congenital disorders or craniofacial anomalies such as cleft lip and palate

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Fahd Ayad hammoodi Al-janabi

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: November 23, 2020
• Study Start: November 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)