This is a 12-month longitudinal, double-blind, parallel-design randomized controlledclinical trial involving surgical therapeutic intervention (Phase 4). It will include 50participants aged 21 diagnosed with periodontitis (Stage III/IV, Grade A or B), dividedinto a Test Group (n=25, Minimally invasive single-flap surgery) and a Control Group(n=25, Minimally invasive double-flap surgery). The objective of this randomized,double-blind clinical study is to compare clinical, radiographic, and patient-centeredoutcomes between minimally invasive single-flap and double-flap techniques in treatingisolated infra-bony defects. Twenty-five patients will be treated using the single-flapapproach, and 25 patients will receive the double-flap elevation technique. Clinicalparameters (plaque and bleeding scores, probing depth, gingival recession, clinicalattachment level, and papillary dimensions), digital measurements (changes in gingivalmargin and papillary volume), radiographic assessments, and patient-centered outcomes(VAS scale) will be evaluated immediately before surgery, at 6 and 12 monthspost-procedure, while early healing will be assessed after 1 and 2 weeks following theprocedures. Mean values and standard deviations will be calculated for each variable,normal distribution will be tested using the Shapiro-Wilk test, and comparisons will beconducted using Student's t-test and one-way ANOVA. A significance level of 5% will beused for all analyses.
This is a clinical trial, a randomized controlled double-blind parallel-design study with
a 12-month follow-up. Participants will be recruited from patients diagnosed with
periodontitis (Stage III/IV, Grade A or B) based on inclusion and exclusion criteria at
the Postgraduate Periodontics Clinic of the Dental College of Piracicaba in the State
University of Campinas (FOP-UNICAMP). The sample size calculation was based on a previous
study, resulting in 50 participants, with 25 in each group. Participants will be randomly
assigned to two treatment groups: Control Group (double-flap minimally invasive surgery)
and Test Group (single-flap minimally invasive surgery).
This study will include clinical, digital, radiographic and patient-related outcome
measures parameters. Clinical parameters including plaque index, bleeding on probing,
probing depth, gingival recession, clinical attachment level, and early healing index
will be measured at baseline, 6 months, and 12 months. Digital parameters, including mean
change in papillary volume (mmVP) and change in gingival margin (mGM), will be assessed
through intraoral scanning at baseline and 12 months. Radiographic measurements (linear,
angular, and subtraction) will be performed before surgery and 12 months after using
specialized software. Patient perception of pain and analgesic consumption will be
evaluated using the Visual Analogue Scale (VAS) at various time points post-surgery (1-14
days after surgical intervention).
The clinical protocol involves pre-surgical therapy, surgical therapy, and post-operative
care. After recording all the parameters through periodontal evaluation, X-ray
acquisition procedures and intraoral scanning, a full-mouth supra and subgingival scaling
and root planing will be performed. Afterwards, the surgery will be performed, following
the randomization. Patients will receive post-operative analgesics and instructions for
oral hygiene modifications. Periodontal maintenance will occur at specific intervals
after surgery (1 month after surgery, 2 months after surgery, 4 months after surgery, 7
months after surgery, 10 months after surgery and 12 months after surgery).
For the statistical analysis, descriptive statistics will be used, and normality will be
tested. Comparisons will be made using Student's t-test, one-way ANOVA, or non-parametric
tests if data do not follow a normal distribution. A significance level of 5% will be
used for all analyses.
Procedure: M-MIST
This is characterized by a vestibular mucoperiosteal envelope flap without relaxing
incisions. Sulcular incisions will be made on the vestibular surface of the teeth
included in the surgical area, adjacent to the infraosseous defect. The mesiodistal
extension of the flap will be kept to a minimum necessary to access the defect. In the
papillary area over the infraosseous defect, an oblique or horizontal incision will be
made at the level of the interdental papilla, following the contour of the bone crest.
The vestibular flap will be elevated, leaving the lingual/palatal portion adhered, only
to allow access to the bone defect. The defect will be instrumented with mini-curettes
and specific ultrasonic tips, and the defect will be filled only with a blood clot after
this procedure. Primary closure will be achieved with internal vertical and/or horizontal
mattress sutures, which may be complemented with simple sutures, all using specific
suture threads.
Other Name: Minimally invasive single flap technique
Procedure: MIST
A vestibular envelope flap, without vertical relaxing incisions, will be raised on the
vestibular and lingual/palatal sides. Primary intrasulcular incisions will be made to the
alveolar crest, encompassing the teeth included in the surgical area. In the
interproximal area, incisions will follow the principle of preserving the papilla
(Modified Papilla Preservation Technique = MPPT or Simplified Papilla Preservation Flap =
SPPF), depending on the available interproximal space (Cortellini et al., 1995, 1999).
The mesiodistal extension of the flap will be minimized to provide adequate access to the
defect. The defect will be instrumented using mini-curettes and specific ultrasonic tips,
and the defect will be filled only with a blood clot after these procedures. Flap closure
will be achieved with internal horizontal and/or vertical mattress sutures, which may be
modified or complemented with simple sutures, all using specific suture threads.
Other Name: Minimally invasive double flap technique
Inclusion Criteria:
- Systemically healthy individuals
- Diagnosis of periodontitis (stage III/IV - grade A or B)
- Presence of 20 or more teeth in the oral cavity
- Presence of at least one isolated interproximal infra-bony defect (without extension
of the defect to the lingual or palatal area - assessed with preoperative bone
sounding), with a probing depth of 6 mm or more, and a radiographic infra-bony
component ≥ 4 mm, not associated with bifurcation areas, in anterior or premolar
teeth (Schincaglia et al., 2015)
- Plaque index and bleeding on probing index ≤ 20% (baseline)
- Individuals providing informed and voluntary consent
Exclusion Criteria:
- Individuals who are not available for study evaluation appointments
- Systemic conditions that contraindicate periodontal surgery
- Patients requiring prophylactic antibiotics
- Compromised systemic condition (leukocyte dysfunction, bleeding disorders,
neoplasms, uncontrolled metabolic or endocrine disorders, HIV infection)
- Individuals using bisphosphonates (oral or injectable use)
- Individuals using antibiotics and steroids (within 6 months prior to the study
start)
- Illicit drug users
- Smokers
- Individuals with the tooth associated with the infra-bony defect having inadequate
restoration, endodontic lesion, inadequate endodontic treatment, untreated carious
lesions, and Grade III mobility
- Pregnant and lactating Women
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, Brazil
Thais FM Paschoal, MsC, Principal Investigator
University of Campinas, Brazil