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Completed

NCT Number: NCT03883438

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors, Baku, Azerbaijan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Modified coronally advanced flap and acellular dermal matrix graft

Procedure

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

Primary outcomes

  1. Complete root coverage

    Time frame: 12 months

    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.

  2. Root coverage esthetic score

    Time frame: 12 months

    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.

  3. Patient satisfaction score

    Time frame: 12 months

    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).

Secondary outcomes

  1. Plaque Index

    Time frame: 12 months

    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

    • - 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.
    • - 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.
    • - Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
  2. Gingival Index

    Time frame: 12 months

    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

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

    Time frame: 12 months

    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.

  4. Probing Depth

    Time frame: 12 months

    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.

  5. Clinical Attachment Level

    Time frame: 12 months

    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

  6. Recession Depth

    Time frame: 12 months

    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

  7. Recession Width

    Time frame: 12 months

    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

  8. Gingival Thickness

    Time frame: 12 months

    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.

  9. Keratinized Tissue Width

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

Other

Collaborators

  • Altinbas University
  • Universidad El Bosque, Bogotá
  • Universidade Ibirapuera

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2019
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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