An interventional study of Open flap debridement with osteoplasty and Open flap debridement without osteoplasty in Furcation Defects and Periodontal Diseases, sponsored by University of Oslo. Withdrawn at 1 site in Norway. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University of Oslo · Not applicable, Interventional, and Treatment
Teeth with furcation grade II defects will be treated with open flap debridement, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade II defects with open flap debridement.
42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.
Browse Furcation Defects studies →University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area.
Procedure: Open flap debridement with osteoplasty · Procedure: Open flap debridement without osteoplasty
In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed.
Procedure: Open flap debridement with osteoplasty · Procedure: Open flap debridement without osteoplasty
Treatment of furcation grade II defect with open flap debridement followed by osteoplasty treatment. Osteoplasty includes altering the bone buccal to the furcation opening to \>90 degrees relative to the apico-coronal axis of the toot.
Treatment of furcation grade II defect with open flap debridement only.
Sites with no signs of inflammation
Proportion of sites without inflammation, defined as no BoP or PPD\>4mm following treatment
Time frame: 12 months after treatment
Sites with no signs of inflammation
Proportion of sites without inflammation, defined as no BoP or PPD\>4mm following treatment
Time frame: 24 months after treatment
Changes in patient-reported quality of life (QoL)
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected; (2) less than once a month; (3) once or twice a month; (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected; including category (1)
Time frame: Preoperatively compared to 24 months after treatment
Changes in patient-reported quality of life (QoL)
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected; (2) less than once a month; (3) once or twice a month; (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected; including category (1)
Time frame: Preoperatively compared to 12 months after treatment
Loss of clinical attachment level
To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III)
Time frame: 12 after treatment
Loss of clinical attachment level
To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III)
Time frame: 24 months after treatment
Number of participants with caries lesions
To assess caries lesions in furcation defects following therapy. Caries lesions are assessed clinically with an explorer as caries (Y/N)
Time frame: 24 months after treatment
Radiographic changes
To assess bone loss as measured on standardized radiographs (in mm)
Time frame: 12 months after treatment
Radiographic changes
To assess bone loss as measured on standardized radiographs (in mm)
Time frame: 24 months after treatment
Plan to share: No
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This study is withdrawn, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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