Clinical trial NCT03584906: Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.
Official title: Comparison of Graft Quality and Patient Morbidity Following Four Different Connective Tissue Graft Harvesting Techniques. A Randomized Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Palate; Wound
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare four different connective tissue graft harvesting technique in terms of graft quality and patient post-operative morbidity

Detailed description: The primary aim is to compare 4 different connective tissue graft harvesting techniques in terms of morbidity and in terms of quality of the graft.

The secondary aim is to evaluate the outcome of gingival recessions treated with grafts obtained from different harvesting approaches, in terms of mean root coverage, complete root coverage, keratinized tissue gain, clinical attachment level gain and gingival thickness

Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater,
* Patients with no reported systemic diseases,
* Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy,
* Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of \< 15%,
* Clinical indication for periodontal plastic surgery utilizing CTG to treat either a single or a maximum of two recession defects (Miller class I, II) around natural teeth
* No history of previous palatal harvesting

Exclusion Criteria:

* Pregnancy
* Systemic condition that generally precludes surgical therapy or that could influence the outcome of therapy (e.g. Diabetes with HbA1c \> 7%, INR \> 3 etc.)
* Non-compensated systemic disease
* Poor oral hygiene with full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) \> 20% at baseline
* Inadequate endodontic treatment or tooth mobility at the site of surgery
* Radiographic evidence of bone loss

Primary outcomes:
measure: Patient morbidity (VAS)
timeFrame: 14 days
measure: Mean root coverage (mRC)
timeFrame: 6 months
Secondary outcomes:
measure: Clinical attachment level (CAL) gain
timeFrame: 6 months
measure: Gingival thickness (GT)
timeFrame: 6 months
measure: Patient willingness for retreatment
timeFrame: 14 days
measure: Painkillers consumption
timeFrame: 14 days
measure: Root coverage Esthetic Score (RES)
timeFrame: 6 months
measure: Keratinized tissue (KT) gain
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: University of Milan
city: Piacenza
country: Italy
facility: Studio Odontoiatrico
Study officials:
affiliation: University of Milan
name: Giulio Rasperini, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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 Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
citation: Tavelli L, Barootchi S, Nguyen TVN, Tattan M, Ravida A, Wang HL. Efficacy of tunnel technique in the treatment of localized and multiple gingival recessions: A systematic review and meta-analysis. J Periodontol. 2018 Sep;89(9):1075-1090. doi: 10.1002/JPER.18-0066. Epub 2018 Aug 13.
citation: Tavelli L, Ravida A, Saleh MHA, Maska B, Del Amo FS, Rasperini G, Wang HL. Pain perception following epithelialized gingival graft harvesting: a randomized clinical trial. Clin Oral Investig. 2019 Jan;23(1):459-468. doi: 10.1007/s00784-018-2455-5. Epub 2018 Apr 30.
citation: Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.
citation: Lorenzana ER, Allen EP. The single-incision palatal harvest technique: a strategy for esthetics and patient comfort. Int J Periodontics Restorative Dent. 2000 Jun;20(3):297-305.