Alternative Gingival De-Epithelialization Techniques

NCT05947305 | Enrolling By Invitation

• 1 other identifier: HUM00231789
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare different de-epithelialization methods in patients undergoing soft tissue augmentation surgery. The main questions it aims to answer are: • Which technique is superior for de-epithelialization in terms of remaining epithelium, wound healing of the donor site, and clinical outcomes?

Conditions

Recession, Gingival; Surgical Procedure, Unspecified; Graft Complication; Wound Heal

Outcome Measures

Primary Outcomes (1)

• Histomorphometric Comparison

  Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG

  After Day 0 (Baseline surgery)

Secondary Outcomes (3)

• Surgical Time

  Day 0 (Baseline Surgery)

• Patient-reported outcome measures

  Days 1, 7, 14, 21 (Post-operative) after surgery

• Wound healing

  Days 1, 7, 14, 21 (Post-operative) after surgery

Study Arms (4)

Surgical Blade

PLACEBO COMPARATOR

A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Procedure: Surgical Blade

Mucotome

EXPERIMENTAL

A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Procedure: Mucotome

Diamond Bur

EXPERIMENTAL

A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Procedure: Diamond Bur

Er:YAG Laser

EXPERIMENTAL

A dental laser will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Procedure: Er:YAG Laser

Interventions

Diamond Bur PROCEDURE

Using a surgical diamond bur to de-epithelialize the soft tissue intra-orally

Diamond Bur

Er:YAG Laser PROCEDURE

Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally

Er:YAG Laser

Surgical Blade PROCEDURE

Using a 15c blade to de-epithelialize the soft tissue extra-orally

Surgical Blade

Mucotome PROCEDURE

Using Megagen Mucotome to de-epithelialize the soft tissue intra-orally

Mucotome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status Classification I or II
• Subjects undergoing periodontal surgical procedures that involve harvesting of soft tissue samples, who have a treatment plan including the use or removal of keratinized mucosa or subepithelial connective tissue that will not require additional anesthesia for sample collection
• Adequate physical and mental health to undergo routine dental treatment
• Ability and willingness to follow instructions related to the study procedures

You may not qualify if:

• Poorly controlled diabetes, defined as HbA1c \>/= 7.0
• Autoimmune or inflammatory conditions such as systemic lupus erythematous, rheumatoid arthritis.
• Pregnant women or nursing mothers, or unsure of pregnancy status (self-reported)
• Severe hematologic disorders, such as leukemia or hemophilia
• Subjects on anticoagulant or antiplatelet therapy
• Local or systemic infection that may interfere with healing
• Hepatic or renal diseases
• Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy
• History of antibiotic or immunosuppressant use in the last 3 months
• Subjects on concomitant drug therapy for systemic conditions that may affect outcomes of the study
• Current smokers (CDC definition): heavy smokers: subjects who have smoked \>10 cigarettes per day within 6 months of study onset, and have smoked \>100 cigarettes in their lifetime

Sponsors & Collaborators

• University of Michigan: lead
• Delta Dental Foundation: collaborator

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (16)

• Zucchelli G, Tavelli L, McGuire MK, Rasperini G, Feinberg SE, Wang HL, Giannobile WV. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. J Periodontol. 2020 Jan;91(1):9-16. doi: 10.1002/JPER.19-0350. Epub 2019 Oct 6.

  PMID: 31461778 BACKGROUND

• Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.

  PMID: 18584934 BACKGROUND

• Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.

  PMID: 24640997 BACKGROUND

• Dellavia C, Ricci G, Pettinari L, Allievi C, Grizzi F, Gagliano N. Human palatal and tuberosity mucosa as donor sites for ridge augmentation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):179-86. doi: 10.11607/prd.1929.

  PMID: 24600654 BACKGROUND

• Sanz-Martin I, Rojo E, Maldonado E, Stroppa G, Nart J, Sanz M. Structural and histological differences between connective tissue grafts harvested from the lateral palatal mucosa or from the tuberosity area. Clin Oral Investig. 2019 Feb;23(2):957-964. doi: 10.1007/s00784-018-2516-9. Epub 2018 Jun 18.

  PMID: 29915931 BACKGROUND

• Tavelli L, Barootchi S, Ravida A, Oh TJ, Wang HL. What Is the Safety Zone for Palatal Soft Tissue Graft Harvesting Based on the Locations of the Greater Palatine Artery and Foramen? A Systematic Review. J Oral Maxillofac Surg. 2019 Feb;77(2):271.e1-271.e9. doi: 10.1016/j.joms.2018.10.002. Epub 2018 Oct 11.

  PMID: 30395825 BACKGROUND

• Edel A. Clinical evaluation of free connective tissue grafts used to increase the width of keratinised gingiva. J Clin Periodontol. 1974;1(4):185-96. doi: 10.1111/j.1600-051x.1974.tb01257.x. No abstract available.

  PMID: 4533490 BACKGROUND

• Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.

  PMID: 3866056 BACKGROUND

• Harris RJ. The connective tissue and partial thickness double pedicle graft: a predictable method of obtaining root coverage. J Periodontol. 1992 May;63(5):477-86. doi: 10.1902/jop.1992.63.5.477.

  PMID: 1527693 BACKGROUND

• Carranza N, Rojas MA. Bilaminar Palatal Connective Tissue Grafts Obtained With the Modified Double Blade Harvesting Technique: Technical Description and Case Series. Clin Adv Periodontics. 2020 Dec;10(4):186-194. doi: 10.1002/cap.10124. Epub 2020 Sep 20.

  PMID: 32862553 BACKGROUND

• Wei PC, Geivelis M. A gingival cul-de-sac following a root coverage procedure with a subepithelial connective tissue submerged graft. J Periodontol. 2003 Sep;74(9):1376-80. doi: 10.1902/jop.2003.74.9.1376.

  PMID: 14584873 BACKGROUND

• El-Kholey KE. Efficacy and safety of a diode laser in second-stage implant surgery: a comparative study. Int J Oral Maxillofac Surg. 2014 May;43(5):633-8. doi: 10.1016/j.ijom.2013.10.003. Epub 2013 Nov 7.

  PMID: 24210453 BACKGROUND

• Bosco AF, Bosco JM. An alternative technique to the harvesting of a connective tissue graft from a thin palate: enhanced wound healing. Int J Periodontics Restorative Dent. 2007 Apr;27(2):133-9.

  PMID: 17514885 RESULT

• Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.

  PMID: 14710766 RESULT

• Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.

  PMID: 20590963 RESULT

• Tavelli L, Ravida A, Lin GH, Del Amo FS, Tattan M, Wang HL. Comparison between Subepithelial Connective Tissue Graft and De-epithelialized Gingival Graft: A systematic review and a meta-analysis. J Int Acad Periodontol. 2019 Apr 1;21(2):82-96.

  PMID: 31522155 RESULT

MeSH Terms

Conditions

Gingival Recession

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Sandra Stuhr, DMD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Dentistry, Periodontics and Oral Medicine

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 17, 2023
• Study Start: April 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)