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Gingival RecessionNCT04584931

Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap

A study testing coronally advanced flap and restorative intervention in people with Gingival Recession, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Treatment of gingival recession requires favourable anatomical conditions and the use of invasive surgical approaches. Hence, these procedures are not always indicated in all cases and can cause great pain and morbidity. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
coronally advanced flap and restorative intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Oct 2021to 30 Dec 2022
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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • participants with at least one buccal gingival recession
  • O'Leary plaque index less than 20%
  • motivated participants willing to complete the follow up

Who cannot join

  • prior surgical or restorative interventions at the recession defect
  • smokers
  • pregnant participants
  • systemic conditions contraindicating dental management

Trial locations and contacts

No sites are listed yet.

Karim Fawzy El-Sayed, PhD contact

About this study

Official title: Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap: Controlled Clinical Trial

Treatment of gingival recession requires favourable anatomical conditions and the use of invasive surgical approaches. Hence, these procedures are not always indicated in all cases and can cause great pain and morbidity. Coloured composite restorations that mimic the lost gingival tissues can provide a non-invasive and simple solution regardless of the recession soft and hard-tissue conditions.

Read the detailed description

Gingival recession (also known as marginal tissue recession) is defined as the downward displacement of the soft tissues around teeth that would have been otherwise covering the cemento-enamel junction (CEJ), thus exposing the root surface clinically. Recession is one of the most prevalent mucogingival conditions worldwide, affecting between 30% to 100% of the overall population, and its incidence increases with age. Main concerns regarding recession ranging from unacceptable esthetics to the patient, dentinal hypersensitivity, development of carious and non-carious cervical lesions, or impairment of adequate plaque control.

The ultimate aim for treating gingival recession is to provide complete coverage of the root with optimal esthetics and function. A wide range of surgical interventions have been investigated to provide for successful root coverage including rotational and advanced pedicle flaps, free gingival grafts, or regenerative modalities such as guided tissue regeneration. The predictability of surgical techniques depends on patient related factors such as smoking, oral hygiene care and compliance, defect related conditions like depth, width, gingival thickness and interdental attachment level, and finally, operator related skills and experience.

Coronally advanced flap (CAF) with or without the use of connective tissue graft is considered the gold standard for root coverage due to its ability to achieve complete root coverage in favorable defects, superior esthetic outcomes and blending with surrounding gingiva, and the possible realignment and increase in keratinized tissue height. On the other hand, CAF is faced with multiple drawbacks. Complete root coverage in CAF procedures is not predictable in cases with interdental attachment loss. The surgery poses added morbidity, discomfort and pain, and donor site (if present) may augment these complications. Scar formation as a result of incisions or sutures may reduce the overall esthetic appeal. It requires frequent follow-up visits and arduous post-operative instructions. Post-operative results are not stable over long period of time with frequent relapse. The procedure cannot be performed in cases with systemic contraindications for surgical interventions. And finally, it is time-consuming and requires surgical skill and training of the operator.

To overcome all of the abovementioned drawbacks of CAF, composite resin restorative material with pink shades known as "gingival composite" has been proposed to manage gingival recessions. Root coverage with composite is known to effectively reduce dentinal hypersensitivity effectively. Hence, managing gingival recession with this restorative procedure, the patients concerns regarding esthetics or hypersensitivity can be directly addressed using a simple and fast technique. Compared to CAF, restorative procedure shows less pain, morbidity and bleeding, and it does not involve surgical incisions/sutures and hence avoids no scar formation. Pink composite can be presented as a solution in cases that are not expected to benefit from CAF such as RT3, and it can treat carious and non-carious cervical lesions in one step. In addition, it requires less operative time and can be performed by general practitioners and with conventional armamentarium.

Being tested
coronally advanced flap, restorative intervention
Medical subject headings
Gingival Recession

What participants receive

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

  • coronally advanced flapProcedure or surgery

    flap surgery to achieve root coverage at gingival recession defect

  • restorative interventionProcedure or surgery

    colored composite restoration to camouflage the gingival recession defect

Study groups in NCT04584931
Study groupRoleWhat they receive
Treatment of gingival recession with colored compositeExperimentalComposite restoration will be applied to the gingival recession defect
Receives: Procedure: restorative intervention
Treatment of gingival recession with coronally advanced flapActive comparatorcoronally advanced flap at the gingival defect
Receives: Procedure: coronally advanced flap

What is being measured

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

  1. post-operative pain

    self-reported pain on visual analogue scale (VAS)

    Measured: 7 days

Secondary outcomes (9)
  1. post-operative pain

    self-reported pain on VAS

    Measured: 1,3,5,14 days

  2. overall quality of life: questionnaire

    self reported through a questionnaire

    Measured: 6 months

  3. Reported post-operative satisfaction

    questionnaire

    Measured: 6 months

  4. mean root coverage

    percentage

    Measured: 6 months

  5. complete root coverage

    percentage

    Measured: 6 months

  6. Probing depth

    in mm

    Measured: baseline, 6 months

  7. Recession depth

    in mm

    Measured: baseline, 6 months

  8. Plaque index

    percentage

    Measured: baseline, 6 months

  9. Bleeding index

    percentage

    Measured: baseline, 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 posted14 Oct 2020
  2. Study start1 Oct 2021 (estimated)
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04584931
Sponsor's protocol ID
1:3:7
Status last verified
Oct 2020
First submitted
3 Oct 2020
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing coronally advanced flap and restorative intervention in people with Gingival Recession, run by Cairo University.

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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Ahmed Elfana, MSc (+2011101102221, ahmed.abdelraouf@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

post-operative pain (time frame: 7 days). 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 14 Oct 2020.

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