Clinical Evaluation of Single-stage Advanced Versus Rotated Flaps in the Treatment of Gingival Recessions
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

Summary: 
      BACKGROUND: Several procedures have been reported for the surgical correction of gingival
      recession (GR), including the laterally positioned flap (LPF) and the coronally advanced flap
      (CAF), performed as single or two-stage procedures without or with, respectively, the
      preceding placement and healing of a free gingival graft (FGG). The objective of the present
      report was to compare the efficacy of single-stage LPF and CAF techniques in the treatment of
      localized maxillary GR defects.

      METHODS: Thirty-six patients with Miller class I GR defects were randomly assigned to be
      treated by either a CAF (n=18) or LPF (n=18). Clinical parameters, including recession height
      (RECH), the width of keratinized tissue (WKT), probing depth (PD) and vertical clinical
      attachment level (VAL) were assessed at the mid-buccal site. Visual plaque score (VPS) and
      bleeding on probing (BOP) were also assessed dichotomously. Clinical recordings were
      performed at baseline, 6 months and 5 years later. Inter-measurements differences were
      analyzed with a Chi-square or a Wilcoxon test, with significance set at α<0.05.
    

Detailed description: 
      Population and Experimental Design The study was designed as a randomized, prospective,
      parallel-arm, controlled clinical trial. It was conducted in accordance with the guidelines
      of the Helsinki Declaration of 1975, as revised in 2000, and after approved by institutional
      review board approval. Written informed consent was obtained from all patients after thorough
      explanation of the nature, risks, and benefits of the clinical investigation and associated
      procedures. The study population consisted of patients referred for periodontal treatment at
      the School of Dentistry, Federal Fluminense University, Brazil. The following inclusion
      criteria were used: adult patients with no contraindications for periodontal surgery, and who
      had not taken medications known to interfere with periodontal tissue health or healing in the
      preceding 6 months, exhibiting the presence of Miller class I gingival recessions5 in
      maxillary incisors, canines or premolars, probing depth (PD) <3mm without bleeding on
      probing, presenting tooth vitality and absence of caries or restorations in the areas to be
      treated. Patients with untreated periodontal disease, smokers, subjects with
      immunosuppressive systemic diseases (i.e., cancer, AIDS, diabetes) were not included in the
      study. Miller class II, III or class IV recession defects5, presence of apical radiolucency
      or caries or restorations in the areas to be treated, and previous lack of cooperation with
      the maintenance program were also exclusion criteria. Thirty-six patients (10 men and 26
      women), with average age of 34 ± 7 years, were included in the present prospective study from
      June 2002 to December 2006. Sample size was determined by Power analysis, assuming α of .05,
      two-tailed z value of 1.96 and a standart deviation of 0.72. This calculation indicated that
      with a sample of 16 subjects, the study would have >90% power to detect a 1-mm difference in
      recession depth between the two groups.

      All patients were subjected to initial periodontal therapy and were adherent to maintenance
      care for at least six months before the beginning of the study. Treatment included oral
      hygiene instructions, scaling and root planning where needed, tooth polishing plaque control
      measures and correction of traumatic tooth brushing technique or other negative habits. All
      patients were instructed and trained to use a soft toothbrush and to eliminate habits related
      to the etiology of the recession. Baseline full mouth plaque and bleeding scores were low.
      Each defect (one defect per patient) was randomly assigned to one of the two treatment
      modalities employed: coronally advanced flap (CAF)(n=18) or laterally-positioned flap (LPF)
      (n=18) by the toss of a coin.

      Clinical data collection Clinical parameters were assessed as previously described3 at the
      mid-buccal site from the teeth using the cemento-enamel junction (CEJ) or, when applicable,
      another defined landmark, as a fixed reference point from which REC was recorded. All
      measurements were recorded using an UNC #15 periodontal probe (PCPUNC 15 - Hu-Friedy,
      Chicago, USA) with a rubber stopper by a blinded, trained and calibrated examiner, unaware of
      the treatment provided, at baseline and 6 months after surgery. Measurements were recorded to
      nearest higher mm. The point of maximum convexity of the marginal gingival contour - the
      gingival zenith (GZ) - was employed as the reference for measurements of the gingival margin
      (GM). Visual plaque score (VPS) and bleeding on probing (BOP) were assessed dichotomously at
      the mid-buccal location. Recession height (RECH) was measured as the distance from the CEJ to
      GM. The width of keratinized tissue (WKT) was measured as the distance between the GM and the
      MGJ. PD was measured as the distance from the GM to the bottom of the gingival sulcus.
      Probing depth and gingival recession were used to calculate the vertical clinical attachment
      level (VAL).

      Surgical Procedures Before surgery, each patient was given a single dose of 500 mg sodic
      dipyrone as an analgesic. Intraoral antisepsis was performed with a 0.12% chlorhexidine
      rinse. Anesthesia was obtained by regional blocks with 2.0% Lidocaine with 1:100.000
      epinephrine. Coronally Advanced Flap (CAF). The CAF was designed performing two vertical
      releasing incisions at both the mesial and distal aspects of the recession to be treated, in
      such a way that both the proximal papillae were not included as part of the flap. Papillae
      were never bisected. Beveled vertical incisions were performed in the attached gingiva,
      avoiding the formation of butt-joints between the flap and adjacent tissues, and were
      continued several millimeters apically into the alveolar mucosa. The vertical incisions were
      joined by an intrasulcular incision. In the interproximal area, the papillae were split in a
      mesio-distal dimension, resulting in a flat surface of connective tissue for contact between
      the flap tissues and the retained portion of the papillae after repositioning and suturing of
      the flap. A combined mucoperiosteal-mucosal flap was elevated such that the first 3-4mm
      coronal aspect of the alveolar bone was exposed, while the remaining buccal bone was still
      covered by the periosteum and gingival connective tissue. Thorough root planning was
      performed with hand, rotary and ultrasonic instruments. A fine-grain finishing bur was always
      used to reduce the convexity of the root surfaces and to remove sharp edges and grooves.
      After instrumentation, the root surfaces were washed with saline solution to attempt to
      remove any remaining detached fragments from the defect and surgical field. A complementary
      horizontal incision was performed on the apical aspect of the flap, releasing it from the
      attached periosteum. This allowed the elongation and free coronal positioning of the flap.
      The flap was coronally positioned and maintained in place by means of individual 5.0
      monofilament sutures.

      Laterally Positioned Flap The surgical procedures for the LPF were performed according
      standard techniques1. The receptor site was prepared using a surgical blade. Incisions were
      made in both - mesial and distal - aspects of the recession, in order to remove the
      epithelial attachment and obtain connective tissue surfaces, which extended several
      millimeters apically toward the alveolar mucosa. These incisions were carried out to obtain
      an external bevel on the recipient site of the tooth to be treated, and an internal bevel on
      the adjacent aspect of the flap in such a way that when the flap was rotated and sutured in
      the receptor site a buttjoint relationship was not stablished, and a large surface of contact
      between the connective tissues of the flap and receptor site is established. The excised
      gingival tissues were removed, and the root surface was then instrumented as described above.
      The flap design was outlined by two vertical incisions which extended from the horizontal
      incison to several millimeters apically to the mucogingival junction. A horizontal incision
      was performed either at the gingival, or 1 - 2mm apically, following the marginal gingival
      contour, thus joining the vertical incisions. When the donor site was an edentulous site, a
      beveled linear horizontal incision was performed to optimize the content of keratized tissue
      in the flap. The flap was elevated as full-thickness in the portion adjacent to the recession
      and as partial thickness in the portion distal to the recession. Partial-thickness dissection
      was continued apically and laterally in order to obtain passivity of flap movement and
      absence of muscle pull or periosteal adhesion. The flap was rotated laterally in order to
      completely cover the recession defect and extend for approximatelly 1mm coronal to the CEJ.
      Careful flap suturing was performed in order to position and secure the soft tissues over the
      root surface by means of sling and simple sutures.

      Post-Surgical Care The patients were put on systemic analgesics consisting of 750 mg of
      paracetamol (**) every six hours for four days. A surgical dressing (***) was changed after
      seven days and removed after fourteen days for both groups. The patients were instructed to
      continue their regular home hygiene care, except in the operated area, in which
      tooth-brushing was discontinued for the first 30 days after surgery and plaque control was
      maintained by means of gentle topical applications of chlorhexidine gluconate (2.0%) in
      saturated cotton swabs twice a day. Gentle tooth-brushing with an extra soft-bristle
      toothbrush was then initiated. The sutures were removed two weeks after the surgery.

      Maintenance Schedule Following surgery, all patients were seen weekly during the first three
      months and bi-weekly for the next three months. Maintenance visits consisted of reinforcement
      of oral hygiene procedures and professional supra-gingival coronal polishing. Additional oral
      chemical plaque control was performed once every three months by means of mouth rinses with a
      solution of chlorhexidine gluconate 0.12% BID, for one week.

      Statistical Analysis All descriptive statistics were expressed as mean +/- standard deviation
      (SD). Baseline measurements were subjected to inter-group comparisons, and were analyzed by
      the non-parametric Wilcoxon test or the Chi-square test. Inter-group and intra-group
      comparisons between baseline and six-month measurements were analyzed by the Wilcoxon test or
      the Chi-square test. Wilcoxon's signed ranks test was used for intra-group comparisons and
      the Wilcoxon's rank sums test was used for inter-group comparisons. Statistical significance
      was set at the 95% probability level (P<0.05).
    

Intervention name(s): Test - Laterally positioned flap; Control-Coronally positioned flap; 750 mg paracetamol; chlorhexidine gluconate
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Laterally positioned flap. Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days. chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days.; Coronally positioned flap. Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days. chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days.; Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days; chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days
Intervention MeSH terms: Acetaminophen; Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment