Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

Not Applicable

Completed

• Conditions: Palate; Wound; Gingival Recession

• Registration Number: NCT03584906
• Lead Sponsor: University of Milan

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

Study Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-12
• Study Start: 2018-08-16
• Primary Completion: 2020-05-28
• Status Verified: 2020-06
• Study Completion: 2020-06-15
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient morbidity (VAS)	14 days	Patient post-operative pain measured using a VAS scale
Mean root coverage (mRC)	6 months	mRC measured as a percentage

Secondary Outcome Measures

Name	Time	Method
Keratinized tissue (KT) gain	6 months	KT gain measured in mm
Painkillers consumption	14 days	Painkiller consumption expressed in mg
Root coverage Esthetic Score (RES)	6 months	RES measured using numeric values from 0 to 10
Clinical attachment level (CAL) gain	6 months	CAL gain measured in mm
Gingival thickness (GT)	6 months	CAL gain measured in mm
Patient willingness for retreatment	14 days	Patient willingness for retreatment (related to graft harvesting), if necessary, expressed as "yes" or "no"

Trial Locations

Locations (2)

University of Milan; 🇮🇹 Milan, Italy

Studio Odontoiatrico; 🇮🇹 Piacenza, Italy