Alternatieve gingivale de-epithelisatietechnieken
Alternatieve tandvlees-de-epithelisatietechnieken: een gerandomiseerde gecontroleerde studie
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?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Michigan
-
Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan School of Dentistry
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Surgical Blade
A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. |
Using a 15c blade to de-epithelialize the soft tissue extra-orally |
|
Experimenteel: Mucotome
A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. |
Using Megagen Mucotome to de-epithelialize the soft tissue intra-orally |
|
Experimenteel: Diamond Bur
A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. |
Using a surgical diamond bur to de-epithelialize the soft tissue intra-orally |
|
Experimenteel: Er:YAG Laser
A dental laser will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. |
Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Histomorphometric Comparison
Tijdsspanne: After Day 0 (Baseline surgery)
|
Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG |
After Day 0 (Baseline surgery)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Surgical Time
Tijdsspanne: Day 0 (Baseline Surgery)
|
Time spent removing the epithelium (in minutes) |
Day 0 (Baseline Surgery)
|
|
Patient-reported outcome measures
Tijdsspanne: Days 1, 7, 14, 21 (Post-operative) after surgery
|
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
|
|
Wound healing
Tijdsspanne: Days 1, 7, 14, 21 (Post-operative) after surgery
|
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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Sandra Stuhr, DMD, MS, University of Michigan
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HUM00231789
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .