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Gingival RecessionNCT04826653

Timing Suture Removal on Root Coverage Procedures

A study testing Suture removal in people with Gingival Recession and Suture, run by Universitat Internacional de Catalunya at 2 sites in Spain.

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

Gingival recession is defined as the displacement of the soft tissue margin apical to the cemento-enamel junction with exposure of the root surface. It affects a broad population with presence of periodontal disease as well as periodontally healthy individuals. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gingival Recession, Suture, Root Coverage
What is being tested?
Suture removal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesSpain
Study dates
8 Jan 2020to 22 Dec 2023
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥18 years
  • periodontally and systemically healthy
  • presence of at least two consecutive Cairo type I (RT1) gingival recession defects
  • recession >2mm in depth at the buccal aspect
  • full-mouth plaque and bleeding score ≤20%
  • no previous periodontal surgery; presence of identifiable cemento-enamel junction (CEJ) (a step 1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).

Who cannot join

  • smokers >10 cigarettes a day
  • contraindications for periodontal surgery
  • medications known to affect the gingiva or interfere with wound healing
  • pregnancy and lactating females
  • active orthodontic therapy
  • caries or restorations in the area to be treated.
  • Patients unable to follow post-surgical medication instructions adequately.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites
  • International University of Catalunya

    Barcelona, 08172

  • International University of Catalunya

    Barcelona

Other trials in Spain

About this study

Official title: Influence of Timing Suture Removal on Root Coverage Procedures: a Randomized Prospective Clinical Trial

Gingival recession is defined as the displacement of the soft tissue margin apical to the cemento-enamel junction with exposure of the root surface. It affects a broad population with presence of periodontal disease as well as periodontally healthy individuals. The occurrence of gingival recessions is age-dependent and their development begins relatively early in life. For instance, gingival recessions were noticed in more than 60% of Norwegian 20-year-olds and in more than 90% of the older population. Similar findings were reported in Brazilian and French population. In populations deprived of dental care, the occurrence of gingival recessions was even higher.

Many factors have been implicated in the etiology of gingival recession, including plaque, position of the tooth in the arch and improper toothbrushing. It is difficult to see a single cause for the development of labial gingival recession.

Read more

It has been demonstrated in several investigations that if left untreated, the probability of progression of the recession is high even with good oral hygiene. The indications for treatment of gingival recession are: esthetics, dental hypersensitivity, and the prevention of caries as well as further progression of the recession. Therapeutic options for recessions have been well documented with a high degree of success. Their ultimate goal is the location of the gingival margin coronal to the CEJ, with minimal probing depth and a pleasant soft tissue integration with the adjacent teeth.

With such a prevalent condition, it becomes critical to discriminate when to treat these lesions and which are the anatomical and surgical characteristics that are going to determine the amount of root coverage.

Regarding surgical characteristics, it has been demonstrated that the accomplishment of complete root coverage may be prejudiced by the post-surgical position of the gingival margin (the more coronal to the CEJ the greater the chance to achieve root coverage). The same author conducted a randomized clinical trial showing that the higher the flap tension, the lower the recession reduction. Another surgical factor affecting root coverage may be the use of microsurgical approaches by the use of smaller diameter sutures. According to a recently published systematic review, early suture removal (less than 10 days) can negatively affect root coverage outcome.

The healing process after pedicle graft was investigated in an animal model study. The healing was divided into four different stages, the adaption stage (0-4 days), the proliferation stage (4-21 days), the attachment stage (27-28 days) and the maturation stage (1-6 months). During the proliferation stage, connective tissue invades the fibrin layer from the basal level of the flap, and after 6-10 days a layer of fibroblasts is seen in apposition to the root surface. These cells are believed to differentiate into cementoblasts at a later stage of healing. At the end of the proliferation stage, thin collagen fibers are formed adjacent to the root surface, but a fibrous union between the connective tissue and the root has not been observed. It seems logical that stabilizing the flap with sutures for a prolonged period of time during the proliferation phase would help maintain the gingival margin on a more coronal position postoperatively. On the other hand, the longer the sutures remain postoperatively, the greater the chances of plaque accumulation and inflammation affecting negatively to root coverage.

The systematic review by Tatakis and Chambrone included 17 randomized clinical trials that provided an overall data of 325 single recession defects that were treated by coronally advanced flap. While they investigated time of suture removal, the studies included in this study did not account for this variable, thus leading to some bias. Moreover, different suture materials, type of suturing technique may also play an important role in the healing process. Therefore, the aim of this study is to evaluate the clinical outcome of timing suture removal regarding root coverage on coronally advanced flap.

Being tested
Suture removal
Medical subject headings
Gingival Recession

What participants receive

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

  • Suture removalOther

    Suture removal after coronally advanced flap plus a connective tissue graft

Study groups in NCT04826653
Study groupRoleWhat they receive
Timing suture removal_1 weekExperimentalNot described
Receives: Other: Suture removal
Timing suture removal_2 weeksExperimentalNot described
Receives: Other: Suture removal
Timing suture removal_3 weeksExperimentalNot described
Receives: Other: Suture removal

What is being measured

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

  1. Mean Root Coverage (MRC) in percentage (%)

    the average improvement in millimeters of the recession depth will be calculated as a percentage

    Measured: 3- and 6-months post-surgery

Secondary outcomes (4)
  1. Complete root coverage (CRC)

    Measured: 3- and 6-months post-surgery

  2. Change in Keratinized Tissue Width (KT) at 3- and 6-months post-surgery.

    Measured: 3- and 6-months post-surgery

  3. Change in gingival thickness (GT) at 3- and 6-months post-surgery

    Measured: 3- and 6-months post-surgery

  4. Pain and discomfort of the suture of the grafted area.

    Measured: 3- and 6-months post-surgery

Timeline

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

  1. First posted1 Apr 2021
  2. Study start8 Jan 2020
  3. Primary completion1 Jun 2023
  4. Study completion22 Dec 2023

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
Crossover
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04826653
Sponsor's protocol ID
PER-ECL-2019-02
Status last verified
Dec 2023
First submitted
29 Mar 2021
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Suture removal in people with Gingival Recession and Suture, run by Universitat Internacional de Catalunya at 2 sites in Spain.

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 7 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 27 Dec 2023. 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 Spain. 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?

Mean Root Coverage (MRC) in percentage (%) (time frame: 3- and 6-months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Dec 2023.

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Timing Suture Removal on Root Coverage Procedures | AzTrials