Ignite Creation Date:
2024-05-06 @ 3:03 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02195765
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2014-07-16
Brief Title:
Randomized Clinical Trial of Enamel Matrix Derivative Radiographic Analysis
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Two-year Randomized Clinical Trial of Enamel Matrix Derivative Treated Infrabony Defects Radiographic Analysis
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a split-mouth double-blind randomized controlled trial Computerized linear radiographic measurements were used to detect infrabony defects treated with open flap debridement OFD or OFD associated with enamel matrix derivative EMD after 24 months Ten patients presenting 2 or more defects were selected 43 defects An individualized film holder was used to take standardized radiographs at baseline and after 24 months Images were digitized and used to measure the distances from the cemento-enamel junction CEJ to the alveolar crest AC CEJ to the bottom of the defect BD and infrabony defect angle
Detailed Description:
This was a split-mouth randomized controlled trial Patients were recruited among the ones seeking for periodontal treatment at the Post-graduate Clinic of Periodontics using the following inclusion criteria 1 diagnosis of chronic periodontitis15 2 presence of at least one pair of interproximal infrabony defects 2-3 walls adjacent to vital anterior or premolar teeth 3 absence of 2 and 3 mobility degrees16 4 probing pocket depth PPD 5mm 5 full-mouth plaque score 2017 and 6 keratinized tissue width of at least 2mm The exclusion criteria were 1 presence of any systemic disease that could interfere with periodontal treatment 2 infrabony defects with trans-surgical depth 4mm 3 antibiotic treatment administered during the last 6 months
The patients participating in the study were volunteers who received and gave informed consent and were included in the study from June to October 2002
Following initial examination all patients underwent oral hygiene instruction and full-mouth supra- and sub-gingival scaling and root planning under local anesthesia Patients were re-evaluated after completion of the initial therapy to determine their response to therapy and to confirm the need for periodontal surgery Before surgery for each pair of defects one defect was randomly assigned to test EMD and one to control OFD treatment by toss of a coin Both defects were treated at the same surgical time When a patient presented with more than one pair of defects only one pair was treated per day Following local anesthesia all sites were treated with reflection of a full thickness mucoperiosteal flap after intra-sulcular incisions The exposed roots and osseous defects were debrided with hand instruments and the surgical wound was rinsed with saline
After that the flaps of the OFD sites were repositioned and sutured using 5-0 nylon sutures The EMD sites were dried with non-woven gauze roots were conditioned with 24 ethylenediaminotetracetic acid EDTA gel pH 67 for 2 minutes The defect was thoroughly rinsed with saline and EMD gel was applied to the root surfaces according to the manufacturers instructions The flaps were then replaced for primary closure and sutured with 5-0 nylon sutures The sutures were removed after 7 days All surgeries were performed by the same investigator All patients were prescribed 012 chlorhexidine digluconate and instructed to rinse gently twice a day for 4 weeks Analgesics were prescribed to be taken as needed and all patients were seen once a week for 8 weeks for professional tooth cleaning Subsequently the patients were maintained in a supportive periodontal program ie professional tooth cleaning and reinforcement of self-administered oral hygiene measures at 2-month intervals up to 6-month time and then every 3 months until final examination at 24 months
Standardized periapical radiographs were taken at baseline evaluation immediately before surgery and at 24 months follow-up Individually customized bite blocks employing a reference occlusal stent and film holders were used to obtain reproducible exposed films at each radiographic control All radiographs were evaluated by a single calibrated examiner blind to time and treatment
Analyses of the radiographic outcomes were performed using computerized linear measurements with image analysis software The radiographs were previously scanned in digital format by a scanner at a resolution of 500dpi8bits
The radiographic analysis was based in anatomical landmarks CEJ BD and AC that were identified on the scanned radiographs All linear measurements were recorded by a blinded calibrated examiner The following outcomes were measured at radiographs taken at baseline and after 24 months
1 Distance from the CEJ to the bottom of the defect BD The most coronal area where the periodontal ligament maintained an even width was identified to measure the most apical extension of the infrabony defect
2 Distance from the CEJ to the bone crest BC
3 Infrabony defect angle was defined by two lines that represented the root surface of the involved tooth CEJ-BD and the bone defect surface BD-BC
The distance from the CEJ to the bottom of the defect BD was considered the primary outcome CEJ-BC and defect angle were secondary outcomes
The patients participating in the study were volunteers who received and gave informed consent and were included in the study from June to October 2002
Following initial examination all patients underwent oral hygiene instruction and full-mouth supra- and sub-gingival scaling and root planning under local anesthesia Patients were re-evaluated after completion of the initial therapy to determine their response to therapy and to confirm the need for periodontal surgery Before surgery for each pair of defects one defect was randomly assigned to test EMD and one to control OFD treatment by toss of a coin Both defects were treated at the same surgical time When a patient presented with more than one pair of defects only one pair was treated per day Following local anesthesia all sites were treated with reflection of a full thickness mucoperiosteal flap after intra-sulcular incisions The exposed roots and osseous defects were debrided with hand instruments and the surgical wound was rinsed with saline
After that the flaps of the OFD sites were repositioned and sutured using 5-0 nylon sutures The EMD sites were dried with non-woven gauze roots were conditioned with 24 ethylenediaminotetracetic acid EDTA gel pH 67 for 2 minutes The defect was thoroughly rinsed with saline and EMD gel was applied to the root surfaces according to the manufacturers instructions The flaps were then replaced for primary closure and sutured with 5-0 nylon sutures The sutures were removed after 7 days All surgeries were performed by the same investigator All patients were prescribed 012 chlorhexidine digluconate and instructed to rinse gently twice a day for 4 weeks Analgesics were prescribed to be taken as needed and all patients were seen once a week for 8 weeks for professional tooth cleaning Subsequently the patients were maintained in a supportive periodontal program ie professional tooth cleaning and reinforcement of self-administered oral hygiene measures at 2-month intervals up to 6-month time and then every 3 months until final examination at 24 months
Standardized periapical radiographs were taken at baseline evaluation immediately before surgery and at 24 months follow-up Individually customized bite blocks employing a reference occlusal stent and film holders were used to obtain reproducible exposed films at each radiographic control All radiographs were evaluated by a single calibrated examiner blind to time and treatment
Analyses of the radiographic outcomes were performed using computerized linear measurements with image analysis software The radiographs were previously scanned in digital format by a scanner at a resolution of 500dpi8bits
The radiographic analysis was based in anatomical landmarks CEJ BD and AC that were identified on the scanned radiographs All linear measurements were recorded by a blinded calibrated examiner The following outcomes were measured at radiographs taken at baseline and after 24 months
1 Distance from the CEJ to the bottom of the defect BD The most coronal area where the periodontal ligament maintained an even width was identified to measure the most apical extension of the infrabony defect
2 Distance from the CEJ to the bone crest BC
3 Infrabony defect angle was defined by two lines that represented the root surface of the involved tooth CEJ-BD and the bone defect surface BD-BC
The distance from the CEJ to the bottom of the defect BD was considered the primary outcome CEJ-BC and defect angle were secondary outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None