Effect of temporary composite-bonded wire splinting on the proportion of sites reaching therapeutic endpoints after surgical Step 3 of periodontal therapy in advanced (stage IV) periodontitis patients: a randomized controlled trial
Treatment of Stage IV periodontitis in adults with hypermobile mandibular anterior teeth undergoing Step 3 periodontal surgery.
Test Group Protocol Participants in the test group will undergo seven scheduled visits throughout the study period. At Visit 1 (baseline), conducted after completion of the Step 2 periodontal treatment, a comprehensive periodontal evaluation will be performed. During this visit, participants will receive oral hygiene instructions (OHI), undergo professional mechanical plaque removal (PMPR), and complete patient-reported outcome measures (PROMs). One week prior to the scheduled surgery (Visit 1a), participants in the test group will receive lingual splint placement according to their randomization assignment, allowing for patient adaptation to the splint before the surgical intervention. Visit 3 will consist of PROMs collection, followed, during the same appointment, by periodontal surgery as clinically indicated. The surgical procedures will be performed according to standard protocols, with the pre-placed lingual splint remaining in situ to provide stabilization during the healing phase. Post-operative follow-up will begin at Visit 4, scheduled 2 weeks after surgery, during which sutures will be removed, gentle ultrasonic supragingival debridement will be performed, antiseptic irrigations will be administered, and splint integrity will be verified. Subsequent follow-up visits will occur at 8 weeks (Visit 5), 16 weeks (Visit 6), and 24 weeks (Visit 7) post-surgery. Each of these visits will include periodontal re-evaluation, collection of PROMs, PMPR, and splint integrity checks. The final visit (Visit 7) will additionally involve splint removal and assessment for potential replacement of the temporary splint with a permanent one, determined by the clinical outcomes observed during re-evaluation. Control Group Protocol Patients in the control group will be evaluated according to the six-visit schedule. Visit 1 (baseline) will be identical to the test group, including a comprehensive periodontal evaluation after Step 2 treatment completion, OHI, PMPR, and PROMs col
1. Age ≥ 18 years 2. Diagnosis of Stage IV periodontitis, according to the 2018 classification, all grades 3. Intact mandibular anterior region (teeth 3.3–4.3) 4. Presence of at least one tooth in the 3.3–4.3 region with a mobility degree of II or III (Miller’s classification) 5. Patients who underwent step 2 of periodontal therapy and are scheduled for surgical step 3 for not having reached the therapeutic endpoints in the intact mandibular anterior region (teeth 3.3–4.3)
1. Inadequate oral hygiene following Step 2 of therapy (Full-mouth plaque score > 25%) 2. Systemic diseases or medical conditions known to affect periodontal healing 3. Presence of infrabony defects deeper than 4mm in 3.3 – 4.3 region; such defects, treatable by regenerative approaches, would preclude the patients to comply with the scheduled follow-up visits of the experiment 4. Smoking >10 cigarettes/day 5. Allergy to latex and any known sensitivity to the dental materials employed