Aim: This prospective multicenter randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of enamel matrix derivatives (EMD). This article reports on early healing events, post-operative morbidity and patient perceptions of the surgical outcomes.
Material and methods: One hundred and seventy-two patients with advanced chronic periodontitis and at least one intrabony defect of > or =3 mm were recruited in 12 centres in seven countries (European Research Group on Periodontology (ERGOPERIO)). Papilla preservation flaps were used to obtain access and primary closure. After debridement, and root conditioning, EMD was applied in the test subjects, and omitted in the controls. Healing was monitored 1, 2, 3, 4, 6 and 12 weeks after surgery. During the first 12 weeks of healing, supracrestal soft-tissue density was evaluated with a computer-assisted densitometric image analysis system (CADIA) using underexposed radiographs taken on a subset of 34 patients. Patient perceptions were evaluated with a questionnaire immediately after the procedure, at suture removal 1 week later and at 1 year.
Results: Subjects reported little intraoperative or post-operative pain or discomfort for both test and controls. Twenty-four percent of controls and 30% of tests (p=0.64) reported a degree of interference with daily activities for an average of 3 and 3.5 days, respectively. Post-surgical edema was noted in 25% of tests and 28% of controls. Wound dehiscence in the interdental portion of the flap was uncommon (14% of tests and 12% of controls at week 1) and of limited size. Root sensitivity was the most frequent post-operative adverse event: it affected 45% of test and 35% of controls (p=0.55). Up to 6 weeks post-operatively, soft-tissue densities were significantly higher in subjects treated with EMD with respect to controls. One year after completion of the surgery, patients reported high levels of satisfaction with the outcomes. The most frequently reported benefits included the ability to preserve a tooth/dentition and to maintain/improve chewing ability. The cost and need for frequent follow-ups were cited as significant drawbacks.
Conclusions: This study portrayed the early healing events, pain, discomfort and adverse events of papilla preservation flap surgery and the 1-year patient perceptions of the benefits and disadvantages of periodontal surgery in intrabony defects. Earlier gains in soft-tissue density were observed following application of EMD. In terms of patient-centered outcomes, however, both procedures performed in a similar manner.