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Recruiting

NCT Number: NCT05633511

Changes of Soft Tissue Grafting: A Randomized Study

To correct gum recession, patient's own tissue from the roof of the mouth is harvested and placed where there is root exposed. This is considered gold standard of treatment. Sometimes patient don't want to have second surgical site in their mouth and at the same time do not want to use alternative tissue from human or animal donor. Using patients' blood and preparing it as a membrane is the next best thing to correct gum recession.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location status: Recruiting

Location contact

Tannaz Shapurian

CONTACT

[email protected]

About this study

Patients that are interested in having corrective surgery for recession due to esthetic concerns or sensitivity will be enrolled in the study. The treatment site will randomly receive the procedure assignment. Intraoral scanner will be utilized to establish pre-op volume and will be repeated at each follow up visit. Total of 12 visits and 5 year duration is anticipated for the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults 18yrs or older
  • Need of MG-tx for 2 or more sites for root coverage RT I and II (Cairo classification)
  • Class A +/-
  • No class V restoration present

Exclusion criteria

  • Patients who do not consent to recommended therapy
  • Patients who smoke
  • Patients who will not be able to comply with follow up protocols
  • Those who self report that they are pregnant.

Treatment and study plan

Split Mouth Design

Procedure

PRF on one side of mouth and CTG on the other side of participant's mouth.

Primary outcomes

  1. Compare autologous PRF & Autogenous CTG

    Time frame: 5 years

    Primary objective of this study is to compare in a split-mouth study the effectiveness of CTG vs. PRF in soft tissue augmentation and volume stability of each treatment modality in correcting the Cairo Class I, II defects in Periodontally affected patients

Study contacts

Contact information is provided by the study sponsor or research team.

Ann-Marie Jacobson

CONTACT

[email protected]

6176363751

Tannaz Shapurian, DDM, MSc

CONTACT

[email protected]

617.636. 6741

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

Volumetric Changes of Soft Tissue Grafting. Comparison of Autologous PRF (Platelet-rich Fibrin ) & Autogenous CTG (Connective Tissue Grafts) . A Split-mouth Randomized Design

Important dates

Study start
2023
Primary completion
2035
Study completion
2036
First posted
Dec 1, 2022
Registry last updated
Apr 29, 2026

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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