This study aimed to assess the efficacy of phenotype modification around teeth following the use of an allogenic grafting material and a xenogeneic collagen matrix.
Design
A non-randomized, non-blinded, single group clinical trial on 15 patients
Settings and conduct
This study would be conducted at the Department of Periodontics, Shahid Beheshti University of Medical Sciences. In cases that surgery would be performed during orthodontic treatment, active treatment would be interrupted 3 weeks prior to the surgery and postponed for 4 months following surgical intervention. An intracrevicular incision would be used to raise a full-thickness flap. Periosteal incisions would be made for passive flap advancement. Demineralized freeze-dried bone allograft would be placed on the bone surface and covered with a xenogeneic collagen matrix. The collagen matrix would be secured with sling sutures. Flap closure would be achieved with internal vertical mattress sutures at interdental areas.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ≥18 years of age; thin periodontal phenotype; absence of gingival inflammation; probing depth ≤ 3 mm; O’Leary plaque index < 20%.
Exclusion criteria: poor oral hygiene; Cairo classification II/III gingival recession; compromised immune system, systemic diseases, or intake of medications; allergy to antibiotics or other medications to be prescribed; pregnancy or breastfeeding in women; presence of parafunctional habits (bruxism or clenching); history of periodontal surgery over the past 12 months; carious cervical lesions; external root resorption; smoking.
Intervention groups
Soft and hard tissue augmentation around teeth using an allogenic grafting material and a xenogeneic collagen matrix.
Periodontal phenotype modification in orthodontic patients
Public title
Periodontal tissue thickness in orthodontics
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
≥18 years of age
Thin periodontal phenotype
Absence of gingival inflammation
Probing depth ≤ 3 mm
O’Leary plaque index < 20%
Exclusion criteria:
Poor oral hygiene
Cairo classification II/III gingival recession
Compromised immune system, systemic diseases, or intake of medications
Allergy to antibiotics or other medications to be prescribed
Pregnancy or breastfeeding in women
Presence of parafunctional habits (bruxism or clenching)
History of periodontal surgery over the past 12 months
Carious cervical lesions
External root resorption
Smoking
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
10
Augmented teeth are the samples in each individual.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo Blv., Evin, Shahid Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-02-01, 1398/11/12
Ethics committee reference number
IR.SBMU.DRC.REC.1398.217
Health conditions studied
1
Description of health condition studied
Thin periodontal phenotype in orthodontic patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tissue thickness
Timepoint
At least 6 months postoperatively
Method of measurement
Gingival thickness would be measured using a an endodontic spreader placed in the center of a silicone stopper and inserted perpendicularly from the midbuccal point (3 mm apical to the gingival margin) through the soft tissues to reach a hard surface.
Probing depth would be measured at 4 points (mesial, distal, midbuccal, and midlingual) from the gingival margin to the bottom of the sulcus. Subsequently, a mean value of the measurements would be calculated for each tooth. Bleeding on probing would be recorded within 60 seconds of probing depth measurement. Gingival recession would be measured from gingival margin to the cementoenamel junction. Vestibular depth would be measured from the midbuccal gingival margin to the mucobuccal fold, while a retractor was placed in the mouth and teeth would be in occlusion. The periodontal probe would be held vertically across the vestibule in line with the axis of each tooth.
Intervention groups
1
Description
Intervention group: All patients receive phase I periodontal therapy. In cases that surgery would be performed during orthodontic treatment, active treatment would be interrupted 3 weeks prior to the surgery and be postponed for 4 months following surgical intervention. Patients rinse their mouth with 0.2% chlorhexidine for 1 minute right before local anesthesia administration (20 mg/mL lidocaine with 1:80,000 epinephrine). An intracrevicular incision with a no.15c scalpel would be used to raise a full-thickness flap extended to two adjacent teeth mesiodistally and 5 mm beyond the mucogingival junction (MGJ) apically. Periosteal incisions would be made for passive flap advancement. The facial aspects of the interdental papillae would be deepithelialized with a microblade to allow final positioning of the flap margin coronal to the cementoenamel junction (CEJ). The exposed root surfaces would be thoroughly planed with a periodontal curette. Demineralized freeze-dried bone allograft (DFDBA; 500-1000 μm; Iranian Tissue Product Co., Tehran, Iran) would beplaced on the bone surface and be covered with a xenogeneic collagen matrix (Mucoderm®, Botiss Biomaterials, Germany). The collagen matrix would be secured with sling sutures (4-0 PLGA, Ethicon, Johnson & Johnson, NJ, USA). Flap closure would be achieved with internal vertical mattress sutures (4-0 Nylon, Ethicon, Johnson & Johnson, NJ, USA) at interdental areas.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Shahid Beheshti University of Medical Sciences