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Trial registered on ANZCTR


Registration number
ACTRN12618001551280
Ethics application status
Approved
Date submitted
11/09/2018
Date registered
17/09/2018
Date last updated
17/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparisons of the Effects of Secondary Healing, Primary Healing and Collagen-Membrane-Based Primary Healing on Bone Level and Periodontal Status After Partially Impacted Mandibular Third Molar Surgery
Scientific title
Comparisons of the Effects of Secondary Healing, Primary Healing and Collagen-Membrane-Based Primary Healing on Bone Level and Periodontal Status After Partially Impacted Mandibular Third Molar Surgery
Secondary ID [1] 296060 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
impacted third molar teeth 309614 0
Condition category
Condition code
Surgery 308428 308428 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study included patients with no history of medical illness or medication that could influence the course of postoperative wound healing and patients with vertical or mesioangular partially impacted third molar teeth (3M) with healthy periodontium. Patients were excluded from randomisation if they had acute pericoronitis, a preexisting abscess or cellulitis, any restorations or carious lesions on the distal surfaces of the adjecent second molar teeth (2M), or pathological conditions associated with the third molar. Oral contraceptive users and smokers were also excluded.
Patients were randomly assigned to three groups: the SC (secondary closure) group, involving partial closure of the extraction site to allow secondary healing; the PC (primary closure) group, involving total closure of the extraction site by sliding the flap to allow primary healing; and the MBPC (membrane-based primary closure) group, involving total closure of the extraction site by sliding the flap and using a collagen membrane.
The examination and clinical selection of the patients was carried out by a single researcher who performed the surgical procedure. Patients were randomised by the envelope method. Postoperative measurements were performed by a third-party blinded researcher who had no information about the patients or their study groups.
Surgical operations were carried out by a single surgeon with each patient under local anesthesia, which was achieved with up to 4 mL of articaine and a 1:100,000 ratio of epinephrine (Ultracaine D-S Forte, Aventis). An incision was made from the anterior border of the mandibular ramus, extending to the distal surface and the buccal gingivodental sulcus of the 2M. The incision was continuous, with a vertical incision, oblique into the mandibular vestibular fornix, aligned with the mesiobuccal cusp of the 2M. A full-thickness mucoperiosteal triangular flap was elevated. If necessary, osteotomy was performed with a bur, and tooth sectioning was performed when necessary under constant irrigation with sterile isotonic saline. After extraction, curettage and elimination of the remaining dental follicle were performed. In all cases, wound closure was carried out with atraumatic silk sutures.
In the MBPC group, a resorbable collagen membrane (Evolution®, Osteobiol-Tecnoss, Italy) was positioned to extend 3–4 mm beyond the margin of the bone defect, and the area was closed in the same way as a primary closure.
The patients were given standard postoperative instructions. Patients were administered antibiotics (amoxicillin + clavulanic acid), nonsteroidal anti-inflammatory drugs (dexketoprofen trometamol) and mouthwash (with 0.12% chlorhexidine). The sutures were removed after 7 days.

Digital panoramic radiographs were obtained preoperatively and three months postoperatively. Cemento-enamel junction (CEJs) was used as reference points, and the distances between the CEJ and the alveolar bone crest on the distal aspect of the adjacent 2M were measured as millimeter using calibrated radiograph measurement software (MedData Medical Software, Ankara, Turkey). All radiological measurements were performed twice and independently, and mean values were recorded preoperatively (T1) and three months postoperatively (T2). The differences (positive or negative) between the pre- and postoperative radiographic measurements constituted one of the primary outcomes of this study.
Another primary outcome variable was the periodontal status of the 2Ms. Periodontal measurements were performed preoperatively (T1) and three months postoperatively (T2). The pocket depths and plaque index scores of the distobuccal (DB), distolingual (DL), midbuccal (MidB) and midlingual (MidL) surfaces of the 2Ms were recorded. All periodontal pocket depth (PPD) measurements were performed as millimeter using William’s periodontal probe (Aesculap AG & Co., Tuttlingen, Germany). To assess the periodontal plaque index (PPI) scores, the Silness & Löe plaque index was registered on the distal aspects of the 2Ms, and the mean values were used.
Intervention code [1] 312396 0
Treatment: Surgery
Comparator / control treatment
With the same procedure, in the SC group, the flap was sutured, leaving a gap without shifting it to its former position by the placing of a single suture distal to the 2M, removing a wedge of mucosa if necessary. In the PC group, the sliding flap was repositioned to allow for healing by primary intention before being sutured to seal off communication with the oral cavity.
Control group
Active

Outcomes
Primary outcome [1] 307395 0
Cemento-enamel junction (CEJs) was used as reference points, and the distances between the CEJ and the alveolar bone crest on the distal aspect of the adjacent 2M were measured as millimeter using calibrated radiograph measurement software (MedData Medical Software, Ankara, Turkey). All radiological measurements were performed twice and independently, and mean values were recorded
Timepoint [1] 307395 0
All radiological measurements were recorded preoperatively (T1) and three months postoperatively (T2).
Secondary outcome [1] 351822 0
Secondary outcome variable was the periodontal status of the 2Ms. The pocket depths of the distobuccal (DB), distolingual (DL), midbuccal (MidB) and midlingual (MidL) surfaces of the 2Ms were recorded. All periodontal pocket depth (PPD) measurements were performed as millimeter using William’s periodontal probe (Aesculap AG & Co., Tuttlingen, Germany).
Timepoint [1] 351822 0
Periodontal measurements were performed preoperatively (T1) and three months postoperatively (T2).
Secondary outcome [2] 351861 0
Plaque index scores of the distobuccal (DB), distolingual (DL), midbuccal (MidB) and midlingual (MidL) surfaces of the 2Ms were recordedTo assess the periodontal plaque index (PPI) scores, the Silness & Löe plaque index was registered on the distal aspects of the 2Ms, and the mean values were used.
Timepoint [2] 351861 0
Periodontal measurements were performed preoperatively (T1) and three months postoperatively (T2).

Eligibility
Key inclusion criteria
Patients with vertical or mesioangular partially impacted 3Ms with healthy periodontium were included.
Minimum age
18 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded from randomisation if they had acute pericoronitis, a preexisting abscess or cellulitis, any restorations or carious lesions on the distal surfaces of the 2Ms, or pathological conditions associated with the 3Ms

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were randomised by the sealed opaque envelope method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Postoperative measurements were performed by a third-party blinded researcher who had no information about the patients or their study groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis was performed using the SPSS statistical software package, version 20.0 (IBM, Chicago, IL, USA). The normalities of the distributions were tested using the Kolmogorov-Smirnov test. The Wilcoxon signed rank test was used for intragroup comparisons. For intergroup comparisons, the Kruskal-Wallis or chi-square tests was used, and for post hoc tests, the Bonferroni correction was used. The study data were subjected to power analysis to check the acceptability of the sample size. The power analysis resulted in a power of more than 0.8; thus, the sample size was found to be appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20837 0
Turkey
State/province [1] 20837 0
Erzurum

Funding & Sponsors
Funding source category [1] 300647 0
University
Name [1] 300647 0
Scientific Research Project Fund of Ataturk University (BAP 2016/091).
Address [1] 300647 0
Scientific Research Project Fund of Ataturk University , 25040, Erzurum,Turkey
Country [1] 300647 0
Turkey
Primary sponsor type
University
Name
Ataturk University
Address
Ataturk University , Faculty of Dentistry, 25040, Erzurum,Turkey
Country
Turkey
Secondary sponsor category [1] 300163 0
None
Name [1] 300163 0
Address [1] 300163 0
Country [1] 300163 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301436 0
Ethical Review Board of the Ataturk University Faculty of Dentistry
Ethics committee address [1] 301436 0
Ethical Review Board of the Ataturk University Faculty of Dentistry , 25040, Erzurum, Turkey
Ethics committee country [1] 301436 0
Turkey
Date submitted for ethics approval [1] 301436 0
01/09/2015
Approval date [1] 301436 0
23/12/2015
Ethics approval number [1] 301436 0
11/2015-59

Summary
Brief summary
This study intended to answer the following hypothesis: Is the administration of collagene membrane after surgical removal of partially erupted impacted 3Ms effective on periodontal healing? This study compared primary and secondary healing and collagen-membrane-based primary healing after surgical removal of partially erupted impacted 3Ms, evaluating the distal alveolar bone level (ABL) and periodontal status of the adjacent 2Ms
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3090 3090 0 0
Attachments [2] 3091 3091 0 0

Contacts
Principal investigator
Name 86990 0
Dr Mert Ataol
Address 86990 0
Mersin University, Faculty of Dentistry
Department of Oral and Maxillofacial Surgery,
Çiftlikköy Campus, 33343, Mersin, TURKEY
Country 86990 0
Turkey
Phone 86990 0
+90 533 368 62 22
Fax 86990 0
Email 86990 0
ataolmert@mersin.edu.tr
Contact person for public queries
Name 86991 0
Dr Mert Ataol
Address 86991 0
Mersin University, Faculty of Dentistry
Department of Oral and Maxillofacial Surgery,
Çiftlikköy Campus, 33343, Mersin, TURKEY
Country 86991 0
Turkey
Phone 86991 0
+90 533 368 62 22
Fax 86991 0
Email 86991 0
ataolmert@mersin.edu.tr
Contact person for scientific queries
Name 86992 0
Dr Mert Ataol
Address 86992 0
Mersin University, Faculty of Dentistry
Department of Oral and Maxillofacial Surgery,
Çiftlikköy Campus, 33343, Mersin, TURKEY
Country 86992 0
Turkey
Phone 86992 0
+90 533 368 62 22
Fax 86992 0
Email 86992 0
ataolmert@mersin.edu.tr

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary