Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.
1 other identifier
interventional
60
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedStudy Start
First participant enrolled
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2020
CompletedJune 30, 2020
June 1, 2020
1.8 years
June 19, 2018
June 29, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Patient morbidity (VAS)
Patient post-operative pain measured using a VAS scale
14 days
Mean root coverage (mRC)
mRC measured as a percentage
6 months
Secondary Outcomes (6)
Clinical attachment level (CAL) gain
6 months
Gingival thickness (GT)
6 months
Patient willingness for retreatment
14 days
Painkillers consumption
14 days
Root coverage Esthetic Score (RES)
6 months
- +1 more secondary outcomes
Study Arms (4)
De-epithelialized gingival graft (DGG)
EXPERIMENTALA harvesting approach where the a graft is obtained from the superficial palate and then extra-orally de-epithelialized in order to obtain a connective tissue graft (DGG harvesting approach) Then the DGG is used for treating gingival recessions (root coverage procedure)
Envelope technique (ET)
EXPERIMENTALA harvesting approach where only one horizontal incision is performed on the palate (ET harvesting approach) for harvesting a connective tissue graft. Then the connective tissue graft is used for treating gingival recessions (root coverage procedure)
Trap door technique (TDT)
EXPERIMENTALA harvesting approach where one horizontal and two vertical incisions are performed on the palate (TDT harvesting approach) for harvesting a connective tissue graft. Then the connective tissue graft is used for treating gingival recessions (root coverage procedure)
Maxillary tuberosity (MT)
EXPERIMENTALA harvesting approach that obtains an epithelialized gingival graft from the maxillary tuberosity (MT harvesting approach) which is then extra-orally de-epithelialized in order to obtain a connective tissue graft. Then the connective tissue graft is used for treating gingival recessions (root coverage procedure)
Interventions
An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Milan
Milan, 20122, Italy
Studio Odontoiatrico
Piacenza, 29121, Italy
Related Publications (5)
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.
PMID: 20590963BACKGROUNDTavelli 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.
PMID: 29761502BACKGROUNDTavelli 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.
PMID: 29713890BACKGROUNDWessel 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.
PMID: 18315424BACKGROUNDLorenzana 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.
PMID: 11203571BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giulio Rasperini, DDS
University of Milan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Periodontology
Study Record Dates
First Submitted
June 19, 2018
First Posted
July 12, 2018
Study Start
August 16, 2018
Primary Completion
May 28, 2020
Study Completion
June 15, 2020
Last Updated
June 30, 2020
Record last verified: 2020-06