Health TrialsbyHealthPanel

Comparison of Two Methods of Covering a Single Lower Front Tooth With Receded Gums

ConditionRecession, Gingival
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Western Reserve University

About this trial

The primary objective of this randomized clinical trial is to compare the mean root coverage achieved with Coronally Advanced Flap (CAF) + Connective Tissue Graft (CTG) (control) to Gingival Pedicle Split Thickness flap (GPST) + CTG (test) for the treatment of isolated gingival recession defects in mandibular incisors. The secondary objectives are to compare the percentage of complete root coverage and keratinized tissue gain between the two techniques.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and females of > 18 years of age

Single Cairo's RT1 (Recession Type 1) and RT2 ( Recession Type 2) recession defects (≥3 mm in depth) in mandibular anterior teeth (Incisors).

Presence of identifiable cemento-enamel junction (CEJ)

Presence of a step ≤1 mm at the CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ, will be accepted

Disqualifiers

Vaping, chewing tobacco or smoking > 10 cigarettes per day

Uncontrolled Diabetes Mellitus (HbA1c > 7)

Pregnancy and Lactation

Diseases affecting connective tissue metabolism

Trial design

Design model

Single group

Treatments tested in this trial

  • Mandibular Incisor root coverage procedure

    Procedure/Surgery

    Mucogingival procedure to cover mandibular incisor tooth with receded gums

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: GPST + CTGExperimental treatment 1 intervention
Group B: CAF + CTGActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of mean root coverage

The mean of the amount of root coverage will be calculated within and between test and control groups.

Time frame
6 months

Secondary outcomes

1

Percentage of complete root coverage

The percentage of teeth that achieved complete root coverage will be compared between test and control.

Time frame
6 months
2

Keratinized Tissue gain.

The changes in the amount of keratinized tissue from baseline to 6 months will calculated within and between study groups

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Western Reserve University

Lead sponsor

Source ClinicalTrials.gov
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