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Treatment of periodontitis using a surgical regenerative therapy

Clinical outcomes of supra-bony defects treated with access flap and enamel matrix derivative or access flap alone: a 12-months randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14189134
Enrollment
26
Registered
2019-02-21
Start date
2015-03-01
Completion date
Unknown
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis Oral Health Chronic periodontitis

Interventions

Depending on the mesio-distal width of the interproximal space, two different incision techniques will be selected to access the intrabony defect area. The modified papilla preservation technique (MMP

Sponsors

University Federico II
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients suffering from chronic periodontitis; 2. Age =18 years old 3. Presence of supra-alveolar-type defects (i.e. defects displaying a predominantly horizontal pattern of bone loss) at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth (FDI positions 15-25 or 35-45) in either the maxilla or the mandible with a PD = 6 mm at a minimum on one site of examined teeth. 4. Intrabony defect with an intrabony component of < 2 mm;

Exclusion criteria

Exclusion criteria: 1. Patients with systemic disease 2. Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery 3. Pregnant or lactating 4. Tobacco smokers 5. Patients with FMPS and FMBS ? 25 % after completion of non surgical periodontal therapy recorded at six sites per tooth) 6. Intra-bony defects = 2 mm or involving furcation involvement; 7. Presence of prothesis reconstructions 8. Multi-rooted teeth

Design outcomes

Primary

MeasureTime frame
Clinical attachement level (CAL) will be measured using the distance from cemento-enamel junction (CEJ), to the bottom of the pocket at six sites per tooth at baseline and after the 12-months follow-up period.

Secondary

MeasureTime frame
1. The total amount of bacteria in the mouth will be measured using the full Mouth Plaque Score (FMPS) at six sites per tooth at baseline and after the 12-months follow-up period. 2. Gingival bleeding will be measured using the full Mouth Bleeding Score (FMBS) at six sites per tooth at baseline and after the 12-months follow-up period. 3. Probing depth will be measured using the distance from the gingival margin to the bottom of the pocket at six sites per tooth at baseline and after the 12-months follow-up period. 4. Gingival recession will be measured using the distance from gingival margin to the cemento-enamel junction (CEJ) at six sites per tooth at baseline and after the 12-months follow-up period. 5. Gingival thickness (GT) in millimeters (mm) will be measured at a buccal location 1 mm apically to the bottom of the sulcus. 6. Probing bone level will be measured using the distance from the cemento-enamel junction (CEJ) to bone crest (BC). 7. Postoperative wound healing will be assessed by the early wound healing index (EHI) according to Wachtel et al 2003.

Countries

Italy, Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026