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Gingival RecessionNCT03584906

Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

A study testing DGG Harvesting approach, ET harvesting approach and TDT harvesting approach in people with Gingival Recession and Palate; Wound, run by University of Milan at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gingival Recession, Palate; Wound
What is being tested?
DGG Harvesting approach, ET harvesting approach and TDT harvesting approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesItaly
Study dates
16 Aug 2018to 15 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • University of Milan

    Milan, 20122

  • Studio Odontoiatrico

    Piacenza, 29121

Other trials in Italy

About this study

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

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

Read the 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

Being tested
DGG Harvesting approach, ET harvesting approach, TDT harvesting approach, MT harvesting approach, Root coverage procedure
Medical subject headings
Gingival Recession, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DGG Harvesting approachProcedure or surgery

    An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft

  • ET harvesting approachProcedure or surgery

    A connective tissue graft is harvested from the palate after reflecting a primary palatal flap

  • TDT harvesting approachProcedure or surgery

    A connective tissue graft is harvested from the palate after reflecting a primary palatal flap

  • MT harvesting approachProcedure or surgery

    An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft

  • Root coverage procedureProcedure or surgery

    A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft

Study groups in NCT03584906
Study groupRoleWhat they receive
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)
Receives: Procedure: DGG Harvesting approach; Procedure: 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)
Receives: Procedure: ET harvesting approach; Procedure: 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)
Receives: Procedure: TDT harvesting approach; Procedure: 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)
Receives: Procedure: MT harvesting approach; Procedure: Root coverage procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient morbidity (VAS)

    Patient post-operative pain measured using a VAS scale

    Measured: 14 days

  2. Mean root coverage (mRC)

    mRC measured as a percentage

    Measured: 6 months

Secondary outcomes (6)

  1. Clinical attachment level (CAL) gain

    CAL gain measured in mm

    Measured: 6 months

  2. Gingival thickness (GT)

    CAL gain measured in mm

    Measured: 6 months

  3. Patient willingness for retreatment

    Patient willingness for retreatment (related to graft harvesting), if necessary, expressed as "yes" or "no"

    Measured: 14 days

  4. Painkillers consumption

    Painkiller consumption expressed in mg

    Measured: 14 days

  5. Root coverage Esthetic Score (RES)

    RES measured using numeric values from 0 to 10

    Measured: 6 months

  6. Keratinized tissue (KT) gain

    KT gain measured in mm

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2018
  2. Study start16 Aug 2018
  3. Primary completion28 May 2020
  4. Study completion15 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03584906
Sponsor's protocol ID
Palatal Harvesting and CTG
Status last verified
Jun 2020
First submitted
19 Jun 2018
Last updated
30 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 20590963

  • 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.

    PubMed 29761502

  • 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.

    PubMed 29713890

  • 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.

    PubMed 18315424

  • 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.

    PubMed 11203571

Questions about this trial

What is this clinical trial studying?

A study testing DGG Harvesting approach, ET harvesting approach and TDT harvesting approach in people with Gingival Recession and Palate; Wound, run by University of Milan at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient morbidity (VAS) (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03584906, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.

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