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Gingival Recession, GeneralizedNCT03883438

Cor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions

A study testing Modified coronally advanced flap and acellular dermal matrix graft in people with Gingival Recession, Generalized, run by Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors at 4 sites in 4 countries.

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

Clinical evaluation of conventional and modified coronally advanced flaps combined with acellular dermal matrix graft 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, Generalized
What is being tested?
Modified coronally advanced flap and acellular dermal matrix graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
4 sitesin 4 countries
Study dates
1 Jan 2014to 15 Feb 2015
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

  • Systemically healthy patients
  • Miller Class I \& II multiple buccal recession defects ≥ 3 mm on maxillary incisors, canines or premolars
  • Esthetic indication for root coverage
  • Probing depth < 3mm at the recession sites

Who cannot join

  • Smokers
  • Pregnancy
  • Bruxism and occlusal trauma
  • Previous root coverage procedure
  • Endodontically treated teeth at the recession sites
  • Caries or restorations at the recession sites
  • Use of antibiotics over the previous 3 months prior to treatment

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Azerbaijan1 site

  • Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

    Baku

Other trials in Azerbaijan

Brazil1 site

  • Ibirapuera University

    São Paulo

Other trials in Brazil

Colombia1 site

  • El Bosque University

    Bogotá

Other trials in Colombia

Turkey (Türkiye)1 site

  • Altinbas University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Coronally Advanced Flap and Envelope Type of Flap Plus Acellular Dermal Matrix Graft for the Treatment of Thin Phenotype Multiple Recession Defects

Clinical evaluation of conventional and modified coronally advanced flaps combined with acellular dermal matrix graft

Read the detailed description

The aim of this study was to evaluate the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I\&II ≥3 mm) treated with coronally advanced flap (CAF) and acellular dermal matrix graft (ADMG) in 22 eligible participants.

Being tested
Modified coronally advanced flap and acellular dermal matrix graft
Keywords
Gingival recession, Therapy, Surgery, Tooth root, Surgical flaps, Acellular dermis
Medical subject headings
Gingival Recession

What participants receive

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

  • Modified coronally advanced flap and acellular dermal matrix graftProcedure or surgery

    Evaluation of the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I\&II ≥3 mm) treated with coronally advanced flap and acellular dermal matrix graft

Study groups in NCT03883438
Study groupRoleWhat they receive
Coronally advanced flap and acellular dermal graftActive comparatorIn CAF group, after local anesthesia oblique beveled vertical incisions were made at the most mesial and distal line angles of the recessions. These two incisions were connected with an intra-sulcular and interdental sub-marginal incisions in order to create the external surgical papillae. Then the flap was elevated as a split-full-split approach. The apical portion of the flap was reflected as close to the periosteum as possible by mesio-distal and apical sharp dissection parallel to the mucosa to release residual muscle tension and extended beyond the muco-gingival junction to facilitate the passive coronal replacement of the flap over the defects. In both groups ADMG was used as a sub-epithelial graft considering the manufacturer's instructions. The graft was positioned at the level of cemento-enamel junction and extended to the surrounding bone in the apical direction with full closure of the exposed root surfaces.
Receives: Procedure: Modified coronally advanced flap and acellular dermal matrix graft
Modified coronally advanced flap and acellular dermal graftExperimentalTest group received CAF avoiding vertical releasing incisions (mCAF).
Receives: Procedure: Modified coronally advanced flap and acellular dermal matrix graft

What is being measured

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

  1. Complete root coverage

    Complete defect coverage was calculated as the percentage of patients with defects having complete coverage achieved as the gingival margin at cemento-enamel junction or coronal level.

    Measured: 12 months

  2. Root coverage esthetic score

    Root coverage esthetic score (RES) was used as a scoring system to assess the esthetic outcomes following root coverage procedures on Miller Class I \& II gingival recession defects through the evaluation of clinical cases. Gingival margin level, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color were evaluated without magnification. Zero, 3 and 6 points were used for the evaluation of the position of the gingival margin, whereas a score 0 or 1 point was used for each of the other variables.

    Measured: 12 months

  3. Patient satisfaction score

    Each patient was questioned about his/her satisfaction with regard to the following patient-centered criteria:

    Root coverage attained, relief from dentinal hypersensitivity, color of gums, shape and contour of gums, surgical procedure in terms of pain during surgery and the discomfort experienced related to the duration of the procedure and handling by the operator, post surgical phase in terms of the pain, swelling, and postoperative complications; and cost effectiveness in terms of the time and money spent for the treatment.

    Patient satisfaction was assessed using a three-point rating scale: fully satisfied (3 points); satisfied (2 points); and unsatisfied (1 point).

    Measured: 12 months

Secondary outcomes (9)

  1. Plaque Index

    Teeth were isolated by cotton rolls and after drying by air syringe, the microbial dental plaque was evaluated by the explorer from 4 tooth surfaces (mesio-buccal, mid-buccal, disto-buccal and mid-palatinal) and scores between 0- 3 were given for each point.

    Scoring was made as follows:

    0 - No microbial dental plaque in the gingival area

    1. - A film of microbial dental plaque adhering to the free gingival margin and adjacent area of the tooth, recognized only by running a probe across the tooth surfaces.
    2. - Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth surfaces that can be seen by the naked eye.
    3. - Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

    Measured: 12 months

  2. Gingival Index

    The periodontal probe was used to assess the bleeding potential of the tissues from 4 tooth surfaces (mesio-buccal papilla, mid-buccal margin, disto- buccal papilla and mid-palatinal margin) and scores between 0 - 3 were given for each point.

    Scoring was made as follows: 0 - Normal gingiva

    1. - Mild inflammation, slight change in color, slight edema; no bleeding on probing (BoP)
    2. - Moderate inflammation, redness, edema, and glazing; bleeding on probing
    3. - Severe inflammation, marked redness and edema, ulcerations; tendency to spontaneous bleeding.

    Measured: 12 months

  3. Bleeding on Probing

    The periodontal probe was used to assess the percentage of bleeding after probing from 4 tooth surfaces (mesio-buccal papilla, mid-buccal margin, disto-buccal papilla and mid-palatinal margin) and scored as positive (+) or negative (-) bleeding for each point.

    Measured: 12 months

  4. Probing Depth

    Probing Depth of the recession defect was measured in mm by the periodontal probe at the mid buccal surface of the related tooth as the distance between the gingival margin and the bottom of the gingival sulcus.

    Measured: 12 months

  5. Clinical Attachment Level

    Clinical Attachment Level of the recession defect was measured in mm by the periodontal probe at the mid-buccal surface of the related tooth and it was defined as the distance between the cemento-enamel junction and the bottom of the gingival sulcus

    Measured: 12 months

  6. Recession Depth

    Recession Depth was measured in mm by the periodontal probe at the mid-buccal surface of the related tooth as the distance between the cemento-enamel junction and the most apical point of the gingival margin

    Measured: 12 months

  7. Recession Width

    Recession Width of the defect was measured in mm by the periodontal probe as the horizontal distance from one border of the recession to another in mesio-distal direction at the level of the cemento-enamel junction

    Measured: 12 months

  8. Gingival Thickness

    Gingival Thickness was measured in mm at the mid-point location between the gingival margin and mucogingival junction, using an #25 endodontic spreader. Under the local anesthesia, the spreader was pierced perpendicularly to the mucosal surface, through the soft tissue with light pressure until hard surface was felt. The silicone disk stop was placed in tight contact with the external soft tissue surface. After carefully removing the spreader, penetration depth was measured with a digital caliper5 with 0.05 resolution.

    Measured: 12 months

  9. Keratinized Tissue Width

    Keratinized Tissue Width of the recession defect was measured in mm by the periodontal probe at the same point as the probing depth, clinical attachment level and recession depth.

    Measured: 12 months

Timeline

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

  1. First posted20 Mar 2019
  2. Study start1 Jan 2014
  3. Primary completion1 Jan 2015
  4. Study completion15 Feb 2015

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
Model description
A total of 22 patients with 55 recessions were included in this single blind randomized controlled trial. Each patient had at least two recessions with a depth of ≥ 3 mm (Miller Class I\&II) in the upper jaw. The entry criteria were esthetic indication for root coverage; absence of caries or restorations at the selected sites; no history of previous mucogingival therapy; being a non-smoker and a systemically healthy patient.
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03883438
Sponsor's protocol ID
AZETR201520171001
Status last verified
Mar 2019
First submitted
17 Mar 2019
Last updated
27 Mar 2019
Results posted
No
Data monitoring committee
Yes
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 Modified coronally advanced flap and acellular dermal matrix graft in people with Gingival Recession, Generalized, run by Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors at 4 sites in 4 countries.

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 4 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Azerbaijan, Brazil, Colombia, Turkey (Türkiye). 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?

Complete root coverage (time frame: 12 months). The study lists 3 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 NCT03883438.

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 Mar 2019.

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