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Completed

NCT Number: NCT04082130

Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession

this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).

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Key information

Conditions

Gingival Recession Localized Moderate

Age range

18 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontics, University of Damascus Dental School

Damascus, Syrian Arab Republic, DM20AM18, Syria

About this study

The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis & Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Good general health.
  • No contraindications for periodontal surgery.
  • Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985).
  • The cemento-enamel junction (CEJ) is visible in the defective teeth.
  • All patients demonstrating good plaque control.
  • No previous periodontal surgery in the targeted area.

Exclusion criteria

  • Smokers.
  • pregnant or nursing patients.
  • history of malignancy, radiotherapy, or chemotherapy.
  • Patients taking medications that affect mucosal healing.
  • Patients with allergy to collagen.
  • Previous participation in a clinical trial.
  • Type-1 diabetes patients.
  • Patient who have diseases that affect connective tissue metabolism.

Treatment and study plan

(XCM)+(CAF)

Procedure

The description of this intervention has been already given before.

(SCTG)+(CAF)

Procedure

The description of this intervention has been already given before.

Primary outcomes

  1. Recession depth (REC): (Change in the amount of root coverage)

    Time frame: 1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.

    from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).

Secondary outcomes

  1. change in visible plaque index:

    Time frame: 1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative

    • Score 0 - No plaque
    • Score 1 - Separate flecks of plaque at the cervical margin of the tooth
    • Score 2 - A thin continuous band of plaque at the cervical margin of the tooth
    • Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth
    • Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth
    • Score 5 - Plaque covering 2/3rd or more of the crown of the tooth

  2. Recession width (RW)

    Time frame: 1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.

    at the cemento-enamel junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).

  3. Width of keratinized tissue (KT)

    Time frame: 1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.

    from the free gingival margin to the mucogingival junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).

  4. Thickness of gingival tissue (GT)

    Time frame: 1) at baseline, and 2) 3 months postoperative.

    with an injection needle and a silicon marker, at the mid-buccal aspect below the gingival margin.

  5. Probing depth (PD)

    Time frame: 1) at baseline, 2) and 3 months postoperative.

    the distance between the gingival margin and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).

  6. Clinical attachment level (CAL)

    Time frame: 1) at baseline, 2) at 3 months postoperative.

    distance between the CEJ and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).

  7. Healing index

    Time frame: 1) at two weeks following surgery and (2) at one month following surgery.

    score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence.

    score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration.

    score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.

  8. Pain index (PI)

    Time frame: 1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.

    Using Visual Analogue scale (VAS) (2001 Crichton), Patients will be asked to select among 100 scores (0 indicating no pain at all , 50 indicating average pain, and 100 indicating very painful).

  9. Patient Perceptions

    Time frame: at three months post-surgery.

    Using 100 cm Visual Analogue Scale (VAS)Patients will be asked to select among 100 scores (0 indicating very bad, 50 indicating average, and 100 indicating excellent results).

  10. Change in root sensitivity

    Time frame: 1) at baseline, 2) and at 3 months postoperative.

    Using a 100 cm-visual analog scale (VAS), patients' root sensitivity will be recorded with zero indicating no pain or sensitivity, 50 indicating moderate pain or sensitivity and 100 indicating worst pain or sensitivity possible.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Clinical Comparison of Coronally-advanced Flap Plus Xenogeneic Collagen Matrix (Fibro-Gide®) and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recessions

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2019
Registry last updated
Jan 12, 2021

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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