Alternative Gingival De-Epithelialization Techniques

Wound Heal Clinical Trial

Official title:

Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05947305
• Other study ID #: HUM00231789
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

Participants will be randomly assigned to one of four surgical techniques during their surgical procedure and the wound site will be assessed on post-operative days 1, 7, 14, and 21. Researchers will compare the use of mucotome, Er:YAG laser, surgical diamond bur, or blade to observe patterns of wound healing and assess if one method is superior in terms of removing the epithelium.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Surgical Blade
Using a 15c blade to de-epithelialize the soft tissue extra-orally
• Mucotome
Using Megagen Mucotome to de-epithelialize the soft tissue intra-orally
• Diamond Bur
Using a surgical diamond bur to de-epithelialize the soft tissue intra-orally
• Er:YAG Laser
Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Delta Dental Foundation

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical Time	Time spent removing the epithelium (in minutes)	Day 0 (Baseline Surgery)
Secondary	Patient-reported outcome measures	Patient-reported outcome measures regarding pain and discomfort after the procedure using a line scale (from no pain to worst pain imaginable), box scale (ranging from 0-10 with 0 being no pain and 10 being worst pain imaginable), and a verbal rating scale (no pain, slightly painful, moderately painful, very painful, extremely painful). The number of analgesics (along with dosage) taken during the post-operative period will be recorded.	Days 1, 7, 14, 21 (Post-operative) after surgery
Secondary	Wound healing	Wound healing comparisons using a clinical healing index (CHI) developed by Pippi et al 2015 will be completed. The possible total score is 7 (ideal score demonstrating ideal healing = 0), with scores for each section being dichotomous (0 or 1). Parameters related to clinical inspection include: mucosal color, granulation tissue, epithelialization degree, and swelling. Palpation parameters include bleeding, pain, and suppuration.	Days 1, 7, 14, 21 (Post-operative) after surgery