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Completed

NCT Number: NCT03032094

Connective Tissue Grafting for Single Tooth Recession & the Impact of the Thickness of the Palatal Harvest Tissue

The purpose of this study is to test if the thickness of the graft taken from the roof of the mouth, has a significant effect on the amount of attached tissue and the amount of root coverage that are attained when treating a single tooth with gingival recession.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The goal of the study is to determine if the thickness of a tissue graft taken from the roof of the mouth, used to cover the exposed root of a tooth, affects the overall outcome of the root coverage, the health of the resulting tissue, as well as postoperative pain as reported by the patient. Connective tissue grafts will be harvested in different thicknesses, and results of the procedures will be compared. Qualified subjects will undergo a root coverage procedure, after random assignment to one of the groups. Regular recall visits to monitor healing at intervals of 1 week, 2 weeks, 1 month, and 3 months will be scheduled. Subjects will be asked to fill out patient response forms regarding pain and other symptoms at these visits. Photographs will be taken.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>18 years old
  • Absence of active periodontal disease
  • Single tooth (premolars and anterior teeth) with Miller class I or II gingival recession >= 2mm
  • Detectable Cemento-Enamel Junction (CEJ) -

Exclusion criteria

  • Smokers (>10 cigarettes/ per day)
  • Uncontrolled systemic diseases with compromised healing potential (DM with HbA1c >7%)
  • Active infectious diseases (hepatitis, tuberculosis, HIV, etc.)
  • Medication known to cause gingival enlargement
  • Patients taking anticoagulants with an international normalized ratio (INR) >2.5
  • Long-term (>2 weeks) use of antibiotics in the past 3 months
  • Pregnant or attempting to get pregnant
  • Sites with probing depth > 4mm
  • Recession adjacent to an edentulous area
  • Frenal and muscle attachment that encroach on the marginal gingiva

a. Can be included 2 months after surgical therapy to remove the frenum (frenectomy)

  • History of periodontal surgical treatment of the involved sites
  • Prosthetic crown, restorations or caries in the candidate tooth and adjacent teeth
  • Teeth with pulpal pathology
  • Severe teeth malposition and open contacts
  • Planned orthodontic treatment to commence within 1 year following procedure
  • Parafunctional habits -

Treatment and study plan

connective tissue graft

Procedure

palatal connective tissue graft to attain root coverage

Primary outcomes

  1. Root coverage

    Time frame: Upto 3 months

    Amount of root coverage attained in millimeters

  2. Root coverage

    Time frame: Upto 3 months

    Amount of root coverage attained in percentage

  3. width of keratinized tissue

    Time frame: Upto 3 months

    Amount of zone of keratinized tissue attained in millimeters

  4. width of keratinized tissue

    Time frame: Upto 3 months

    Amount of zone of keratinized tissue attained in percentage

Secondary outcomes

  1. thickness of keratinized tissue

    Time frame: Upto 3 months

  2. amount of erythema and edema

    Time frame: Upto 3 months

    patient reported outcome of amount of erythema and edema in number of days postoperatively

  3. duration of erythema and edema

    Time frame: Upto 3 months

    patient reported outcome of duration of erythema and edema in number of days postoperatively

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2017
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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