Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

Gingival Recession Clinical Trial

Official title:

Comparison of Graft Quality and Patient Morbidity Following Four Different Connective Tissue Graft Harvesting Techniques. A Randomized Controlled Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584906
• Other study ID #: Palatal Harvesting and CTG
• Status: Completed
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: June 15, 2020

Study information

• Verified date: June 2020
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Palate; Wound

Intervention

Procedure:
• DGG Harvesting approach
An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft
• ET harvesting approach
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
• TDT harvesting approach
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
• MT harvesting approach
An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft
• Root coverage procedure
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft

Locations

Country	Name	City	State
Italy	University of Milan	Milan
Italy	Studio Odontoiatrico	Piacenza

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

Tavelli L, Barootchi S, Nguyen TVN, Tattan M, Ravidà 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. — View Citation

Tavelli L, Ravidà 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. — View 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 . — 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 Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient morbidity (VAS)	Patient post-operative pain measured using a VAS scale	14 days
Primary	Mean root coverage (mRC)	mRC measured as a percentage	6 months
Secondary	Clinical attachment level (CAL) gain	CAL gain measured in mm	6 months
Secondary	Gingival thickness (GT)	CAL gain measured in mm	6 months
Secondary	Patient willingness for retreatment	Patient willingness for retreatment (related to graft harvesting), if necessary, expressed as "yes" or "no"	14 days
Secondary	Painkillers consumption	Painkiller consumption expressed in mg	14 days
Secondary	Root coverage Esthetic Score (RES)	RES measured using numeric values from 0 to 10	6 months
Secondary	Keratinized tissue (KT) gain	KT gain measured in mm	6 months