Periodontitis
Conditions
Brief summary
The primary aim of the study is to evaluate the efficacy of conservative surgery with or without papilla preservation technique in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.
Interventions
PROCEDUREPapilla preservation flap
Surgical access will be obtained using modified papilla preservation techniques and when interproximal space is narrow (less than 3mm in width) incision will be made using the simplified papilla preservation flap. Both flaps buccal and lingual/palatal will be elevated in any case to allow root surface cleaning and defects debridement under direct vision. Minimally invasive flap elevation preventing to damage inter proximal tissues with the preservation of the papilla. Defects debridement with mini-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the pre-surgical level without any tension. Monofilament non-resorbable 5-0 e-PTFE suturing material will be used. Suturing will be performed with external vertical mattress sutures to achieve primary intention closure.
PROCEDUREWidman flap procedure
Surgical access will be obtained using the modified Widman flap technique. Intrasulcular incision will be done on both buccal and lingual/palatal sides without attempting to preserve the interdental tissues and interdental tissues will be removed. Both flaps buccal and lingual/palatal will be elevated at full thickness in any case to allow root surface cleaning and defects debridement under direct vision, a vertical releasing incision could be made when needed. Defects debridement with mini-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the level of the alveolar crest without tension. Monofilament nonresorbable 5 - 0 e/PTFE suturing material will be used. Suturing will be performed with single interrupted sutures.
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stage III/IV periodontitis. * Completed steps I-II periodontal therapy at least 6 weeks before. * Full mouth plaque score of less than 15% at re-evaluation. * Full mouth bleeding score of less than 15% at re-evaluation. * Sextant with residual probing pocket depth (PPD) ≥ 6 mm at ≥ 2 natural teeth (third molars excluded). * Signed informed consent.
Exclusion criteria
* Compromised general health which contraindicates the study procedures (ASA III-VI patients). * Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives). * Pregnant or nursing women. * Presence of tooth mobility ≥ class 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pocket closure | 5 years | Defined as Probing pocket depth of 3 mm or less or Probing pocket depth of 4 mm with the absence of Bleeding on Probing in sites with Probing pocket depth of 6 mm or more at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tooth Retention | 5 years | Number of teeth in the treated sextant will be calculated. |
| Number of instrumentation re-intervention | 5 years | Number of instrumentation re-intervention during supportive periodontal therapy will be calculated |
| Mean Clinical Attachment Level changes | 5 years | Defined as the mean changes in Clinical Attachment Level (distance in mm from the Cemento Enamel Junction to the bottom of the probable sulcus) at the involved sextant with respect to baseline. |
| Mean recession changes | 5 years | Defined as the changes in recession (distance in mm from Cemento Enamel Junction to the gingival margin). |
| Mean Probing Pocket Depth changes | 5 years | Defined as the mean changes in Probing pocket depth (distance in mm from the gingival margin to the bottom of the probable sulcus) at the involved sextant with respect to baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Discomfort during surgery | Immediately after surgery. | Self reported on a 100-mm visual analog scale scale. |
Contacts
Primary ContactMario Aimetti, Prof.
Backup ContactGiacomo Baima
Outcome results
None listed