Comparison of two different mucosal closure techniques after tooth extraction in high risk patients with antiresortive medication intake - a prospective, randomized, blinded feasebility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010106

Enrollment

Registered

2016-03-30

Start date

2016-08-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K10.28

Interventions

Group 1: Arm 1- Subperiosteal wound closure after tooth extraction under antiresorptive medication >3 years Group 2: Arm 2- Epiperiosteal wound closure after tooth extraction under antiresorptive medi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with malignant disease and antiresorptive medication intake planed for preventive tooth extraction

Exclusion criteria

Exclusion criteria: 1. Previous history of a radiation to the head neck region 2. Known metastasis of the jaw 3. exposed bone in the operation field 4. Existing diagnosis MRONJ in the operation field

Design outcomes

Primary

Measure	Time frame
Occurrence of a medication related osteonecrosis of the jaw (MRONJ) eight weeks after operation (Defined by the AAOMS criteria and the german association of maxilla facial surgery)	—

Secondary

Measure	Time frame
1. Postoperative loss of mucosal integrity with/without infection signs (reddening, swelling, pus) 2. Depiction of MRONJ early lesions by loss of auto-fluorescence of the bone 3. Depiction of MRONJ early lesions by histopathological work ups 4. radiologic signs of MRONJ early lesions 5. Quality of life using the EQ-5D scoresheet All secondary endpoints (1-5) are aquired to the following measuring points: 10 days (T1), 30 days (T2), 8 weeks (T3), 4 months (T4), 6 months (T5), 1 year (T6) after operation	—

Measure

Time frame

1. Postoperative loss of mucosal integrity with/without infection signs (reddening, swelling, pus) 2. Depiction of MRONJ early lesions by loss of auto-fluorescence of the bone 3. Depiction of MRONJ early lesions by histopathological work ups 4. radiologic signs of MRONJ early lesions 5. Quality of life using the EQ-5D scoresheet All secondary endpoints (1-5) are aquired to the following measuring points: 10 days (T1), 30 days (T2), 8 weeks (T3), 4 months (T4), 6 months (T5), 1 year (T6) after operation

—

Countries

Germany

Contacts

Public ContactOliver Ristow

Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie

oliver.ristow@med.uni-heidelberg.de+49-6221-56-37314

Outcome results

None listed

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