Adjunctive use of enamel matrix derivatives to porcine derived xenograft for the treatment of one-wall intrabony defects: two-year longitudinal results of a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004164

Enrollment

Registered

2019-08-07

Start date

2017-01-02

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

None listed

Interventions

Procedure/Surgery : 1. Test group: Root conditioning and decontamination were performed using tetracycline (Chong-Kun-Dang, Seoul, South Korea) at a concentration of 50 mg/mL

the tetracycline-soaked cotton pellets were applied to the exposed root surfaces and intrabony defects for two minutes. EMD (Straumann® Emdogain 0.3 ml, Straumann, Basel, Switzerland

Enamel Matrix Derivative 30 mg/ml) was applied to the root surface, followed by appropriate filling of the mixture of demineralized porcine bone matrix (DPBM, THE Graft® 0.25g, Purgo Biologics, Seongn

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) age = 19 years (2) must have completed conventional periodontal treatment (scaling and root planning) at the surgical site (3) presence of a one-wall intrabony defect (> 3 mm) in molar teeth (4) healthy or well-controlled systemic conditions for surgical intervention (patients were American Society of Anesthesiology [ASA]-1 or ASA-2) (5) Adequate plaque control and stable periodontal status (full mouth bleeding score on probing: < 25%, and full mouth plaque score: < 25%).

Exclusion criteria

Exclusion criteria: (1) intrabony defects extending into furcation area (2) Open flap debridement completed within six months at the same surgical site (3) pregnant or lactating women (4) current smokers (5) those who did not fully understand the purpose of the experiment and did not provide informed consent.

Design outcomes

Primary

Measure	Time frame
Changes in the clinical and radiographic parameters of one-wall intrabony defects from baseline, at 6, 12, and 24 months after treatment. Clinical and radiographic parameters included probing pocket depth (PPD), clinical attachment loss (CAL), defect depth, and defect width.	—

Secondary

Measure	Time frame
Postoperative discomfort (severity/duration of pain and swelling) and early soft tissue wound healing (spontaneous bleeding, persistent swelling, and ulceration)	—

Countries

Korea, Republic of

Contacts

Public ContactJae-Hong Lee

Wonkwang University Daejeon Dental Hospital

ljaehong@gmail.com+82-42-366-1114

Outcome results