Periodontitis is a chronic inflammatory disease triggered by gram-negative anaerobic
microbes and involves chronic inflammation that causes the destruction of the
tooth-supporting apparatus and can lead to tooth loss.1 Periodontal disease is
responsible for decreasing alveolar bone height along with morphologic changes of
alveolar bone. Various pattern of bone loss was observed clinically horizontal and
vertical pattern of bone loss are most commonly seen in periodontitis cases.2 Various
factors that determine bone loss patterns are teeth alignments in arch root position
within the alveolar socket and root proximity with the adjacent tooth surface.3 Kern et
al in 1984 called this horizontal bone defect as zero wall defects. In this type of
defect bone margin reduction occurs horizontally and its margin lies perpendicular to
tooth surface. Horizontal pattern of bone loss is most commonly seen in human dentition4
but it receives very less attention in terms of treatment modalities. The prevalence of
vertical bone loss was 7.8% with treatment choices of 96.8% while the horizontal bone
loss prevalence rate was 92.2% and undergo 3.2% treatment options only.5 Due to no bone
wall remaining for the support and stability of grafts and membranes, leads to a very low
success rate of horizontal bone defects treatment modalities. To regenerate the lost part
of the alveolar bone is always a challenge for both clinician and patient.
Several attempts have been done for the treatment of horizontal bone defects using bone
grafts, membranes, or a combination of grafts and membranes. Recently recombinant human
bone morphogenic protein (rhBMP) and enamel matrix proteins(EMPs) have been assessed for
the management of horizontal defects. But their results were mixed and sometimes
disappointing. The single flap approach (SFA) is a simplified minimally invasive surgical
approach that enhances primary closure and minimizes tissue trauma. The principle behind
using this approach is that elevation of the limited mucoperiosteal flap allows surgical
access from either the buccal or palatal/lingual aspect only depending on the extension
of the lesion, leaving the interdental supracrestal gingival tissue intact. Main
advantages associated with this approach that flap repositioning and suturing to the
undetached papilla, thereby preventing contamination by blood clots and reduction in
post-surgical reduction. Due to the emergence of biologic approach and biomaterials there
is improved concern toward of horizontal defects. Various factors determine the outcomes
like patient-related factors, site-related and clinician related factors. Laser
technology now a days becoming popular in various medical applications like photodynamic
therapy. Low level laser therapy (LLLT) also called photo-biomodulation enhance wound
healing based on the principle of biomodulatory capacity of laser on body cells leading
to increased cell activity.12 It reduces excessive post-operative inflammation, edema and
pain. LLLT can promote bone regeneration by enhancing proliferation and differentiation
of human osteoblasts.14 According to Gavish et al 780nm diode laser shown to inhibit the
gene expression of pro-inflammatory cytokines interleukin-1 beta(IL-1β) ,modulate matrix
metalloproteinase (MMPs) activity15 and reduce monocyte chemotactiprotein-1 (MCP-1),
IL-1α, IL-10 and IL-6 in lipopolysaccharide-stimulated macrophages.16 Numerous treatment
approaches for restoring such defects have been investigated. Despite laudable record,
autografts have been questioned for surgical invasiveness, donor site morbidity, limited
quantity of donor material and increased operating time for harvesting procedures.17
Limitations of the use of osteoinductive grafts is variation in bone induction capacity
sourced from different tissue banks.18,19 When used in intrabony defects, Enamel Matrix
Derivative(EMD) may restrict the space provision potential of the preparation.20 Further,
application of EMD is a technique sensitive procedures and contamination of the material
jeopardizing the regenerative potential. The lack of rigidity and rapid degradation
(biodegradability) make the use of PRF for periodontal regeneration difficult.
Nanocomposites and nanostructured materials are thought to have a key function in hard
tissue research, since natural bone tissue is a distinctive model of a nanocomposite.
Collagen has been potentially used in periodontal tissue engineering. The integration of
collagen as a structural protein, serving as an essential component of connective tissue
into three-dimensional scaffolds implanted after periodontal injury, necrosis or
inflammation has attracted much attention in tissue regeneration.
According to Ibara et al, scaffolds to be implanted are durable if composed of
nanoparticles. The nanoparticles facilitate healing process in contact with the tissues
intended for the reformation. Recently, Thoma et al developed and tested collagen-based
matrices as potential devices for soft tissue volume augmentation. Volume stable collagen
matrix (VCMX) is able to overcome the volume stability limitation of most commercially
available grafts.21 It is one of the most biocompatible, novel material to be used in
this study. While mechanical stability is achieved by chemical crosslinking, mechanical
testing demonstrated preserved elasticity of the material over 14 days.22 It has shown
quite impressive results in resolving the intrabony defects in animal studies with an
average of 58.56% of new bone formation .23 Imber J-C et al23, preclinically evaluated
the effect of a volume-stable collagen matrix on periodontal regeneration in two-wall
intrabony defects. This study provided histologic evidence for the potential of this
novel VCMX to facilitate periodontal regeneration. Asparuhova, M.B et al24 investigated
the influence of a novel volume-stable collagen matrix (VCMX) on early wound healing
events including cellular migration and adhesion, protein adsorption and release, and the
dynamics of the hemostatic system. Their study concluded that their data strongly support
the effect of the novel VCMX on fibrin clot stabilization and coagulation/fibrinolysis
equilibrium, thus facilitating progression to the next stages of the soft tissue healing
process.
Therefore, the present study was planned to evaluate the supracrestal regenerative
potential of volume stable collagen matrix (VCMX) along with single flap approach(SFA)
when used with diode laser in the treatment of horizontal bone defect of stage 2 and 3
patients in comparison to OFD with diode laser and OFD alone.
Methodology:
Study design and settings: The study design is "Randomized controlled clinical
trial" and will be conducting in Department of Periodontology, Post graduate
Institute of Dental Sciences, Rohtak, Haryana.
Study population:
Systemically healthy patients with periodontitis stage 2 and stage 3 having horizontal
bone loss will be enrolled in the present study.
I Study conduct: Patients will be enrolled according to inclusion and exclusion criteria
from the outpatient department of periodontics, Post Graduate Institute of Dental
Sciences, Rohtak, Haryana. Informed and written consent will be taken from each patient
in his or her language.
Randomization of patients would be done by generating the allocation sequence using
computer-generated table by another investigator. Patients will be randomly allocated
into:
Control group: using single flap approach only
Test group 1: using collagen matrix and laser therapy in horizontal bone loss
defects by single flap approach (SFA+VCMX+LLLT).
Test group 2: Single flap approach along with diode laser (SFA+LLLT). A balanced,
permuted block approach (in blocks of four and six patients) will be used to prepare
the randomization tables. After the debridement of the bone defect, the eligibility
of the bone defect would be confirmed. Allocation concealment will be performed by
opaque sealed envelopes that would be opened after debridement of horizontal bone
loss defects, and the surgeon will be informed of the allocated treatment. Although
the surgeon won't be blinded to the treatments, the examiners recording clinical and
radiographic parameters would be blind to the treatment groups. Minimum One
horizontal bone defect per patient will be included in the study.
Periodontal parameters:
Parameters recorded for experimental and adjacent teeth will include: PIaque index (PI)
and Gingival Index (GI), assessed at six surfaces (mesiobuccal, midbuccal, distobuccal,
midlingual/midpalatal, mesiolingual, distolingual); bleeding on probing (BOP, %), PPD,
CAL, and gingival recession (REC), examined at six surfaces (mesiobuccal, midbuccal,
disto-buccal, mesiolingual/mesiopalatal, midlingual/midpalatal,
distolingual/distopalatal).
Radiographic Parameters that will be assessed using CBCT will include alveolar crest
changes (ACC).Outcome measures will be revaluated at 3, 6, & 9 months interval
Intervention:
Presurgical patient preparation:
Patients diagnosed with periodontitis who will meet the inclusion criteria will be
screened for periodontal examination. Based on this examination, target sites will be
identified. Each patient will receive the initial phase of the therapy, which will
include oral hygiene instructions, supragingival and subgingival debridement using
ultrasonic (Piezon®, EMS Dental, Nyon, Switzerland) and hand instrumentations (Gracey
Curettes,Hu- Friedy®, Chicago, IL, USA), and relieving of occlusal trauma.
Surgical procedure:
Surgical sites will be anaesthetized using local anaesthesia. Simplified Papilla
Preservation flap technique will be exercised using single flap approach. Crevicular
incisions will be made on buccal/lingual/palatal sites to raise a full-thickness
mucoperiosteal flap. Precaution would be taken to preserve the maximum interdental
gingival tissue at the time of crevicular incision, and no bone recontouring would be
performed. Thorough debridement of the surgical site would be performed For the test
group1, VCMX would be placed according to the dimensions of the horizontal bone loss
defect along with the use of diode laser (LLLT) on the inner epithelium of flap. For the
test group 2, SFA will be done along with the use of diode laser (LLLT). For control
group, SFA will be done. And after this, flap would be approximated and sutured at the
original position with a monofilament suture material using interrupted sutures.
Instructions for maintenance of proper oral hygiene will be reinforced. Study
participants will be scheduled for a follow-up visit weekly to1-month postsurgery and
subsequently at 3-, 6-, and 9-month intervals.
All statistical tests will use two-sided P values, and statistical software will be used
in the analysis of the study data. Differences associated with P values 0.05 will be
considered statistically significant.