Gingival Recession, Palate; Wound
Conditions
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
Interventions
PROCEDUREDGG Harvesting approach
An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft
PROCEDUREET harvesting approach
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
PROCEDURETDT harvesting approach
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
PROCEDUREMT harvesting approach
An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft
PROCEDURERoot coverage procedure
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patient willingness for retreatment | 14 days | Patient willingness for retreatment (related to graft harvesting), if necessary, expressed as yes or no |
| Painkillers consumption | 14 days | Painkiller consumption expressed in mg |
| Clinical attachment level (CAL) gain | 6 months | CAL gain measured in mm |
| Keratinized tissue (KT) gain | 6 months | KT gain measured in mm |
| Root coverage Esthetic Score (RES) | 6 months | RES measured using numeric values from 0 to 10 |
| Gingival thickness (GT) | 6 months | CAL gain measured in mm |
Countries
Italy
Outcome results
None listed