Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03916653 |
| Other study ID # |
prinita perio |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2019 |
| Est. completion date |
June 2020 |
Study information
| Verified date |
April 2020 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to comparatively evaluate changes in periodontal healing, surgical
time required and postoperative morbidity observed in patients undergoing osseous resection
in crown lengthening procedure with conventional rotary instruments versus piezoelectric
device.
Description:
Surgical Crown lengthening (SCL) procedure facilitates restorative and prosthetic
rehabilitation to provide adequate clinical crown structure to teeth which are otherwise
compromised due to subgingival pathologies. One of the main advantages of the surgery is gain
in supragingival crown length which is desirable for restoring severely lost tooth structure.
This procedure provides increase in retention and resistance forms of the tooth necessary for
restorative treatment. Indications of this procedure are subgingival caries, crown & root
fracture, short clinical abutments, cervical root resorption and altered passive eruption.
Gargiulo et al. has given the concept of biologic width the distance between the base of the
gingival sulcus and height of alveolar crest) based on classic histologic study in humans. He
measured the average dimensions of epithelial junction and connective tissue attachment, the
summed value of these dimensions gave biological width (2.04mm=0.97mm+1.07mm). Later on,
Vacek et al.2 examined naturally occurring dimensions in human cadaver histomorphometrically
and measured mean dimensions for epithelial attachment (1.14 +/- 0.49 mm) and for connective
tissue attachment(0.77 +/- 0.32 mm). The average dimensions reported was approximately 2mm.
The importance of biologic width lies in the fact that the violation of this width leads to
gingival inflammation, attachment loss, and alveolar bone resorption. The integrity of
biologic width should be maintained while performing crown lengthening for healthy hard and
soft tissues, required for prosthetic and restorative rehabilitations.
Nevins M et al. and Ingber JS et al. proposed "3mm rule" for crown lengthening. According to
this, 3mm of alveolar bone should be removed during crown lengthening, but this can not be
applicable to all cases. Deas DE et al. in a study demonstrated significant tissue rebound
following crown lengthening which was found to be related to placement of flap with respect
to alveolar crest. More the distance between POST SUTURING Flap position and alveolar crest,
less was the tissue rebound observed.
Osseous surgery in crown lengthening can be performed using rotary & manual instruments like
carbide diamond burs, surgical chisels and files which leads to generation of heat,
post-operative discomfort, swelling and trismus. Vercellotti et al. proposed that
Piezosurgery is a new osteotomy procedure that requires microvibrations at ultrasonic
frequency facilitated to cut hard tissue, while soft tissue remained unaffected. The sites
treated with piezoelectric device had gain in bone level compared to sites treated by carbide
bur or diamond bur. Ma LI et al and Esteves JC et al in a study performed on animals,
demonstrated that the use of piezoelectric device in bone cutting showed advanced bone
healing compared to traditional bone cutting. Sortino et al. proposed that piezosurgery
osteotomy showed less post-operative complications (facial swelling, trismus, discomfort)
although it required longer time for surgery. Verardi S.et al. evaluated and proposed that
piezosurgery showed more favorable response in periodontal compromised patients in terms of
less chewing discomfort, less cold sensitivity and low pain perception at various time points
compared to conventional surgical treatment.
Till date, no studies have compared the periodontal healing, patient based perception of
pain, and discomfort after osseous resection in crown lengthening using piezosurgery with
conventional rotary instruments. The aim of this study is to comparatively evaluate,
clinically and radiographically,the changes in periodontal healing, surgical time required
and postoperative morbidity observed in patients undergoing osseous resection in crown
lengthening procedure with conventional rotary instruments versus piezoelectric device.
The present prospective, analytical, randomized controlled clinical trial will be conducted
in the Department of Periodontics and Oral Implantology, Post Graduate Institute of Dental
Sciences, Rohtak Systemically healthy patients age group 18-60years will participate in this
study. Each patient should have at least one tooth for conducting crown lengthening procedure
either in maxillary or mandibular arch.
Participants will be enlisted from the regular outpatient department of the Department of
Periodontics and Oral Implantology and Department of Oral Medicine and Radiology after
screening on the basis of inclusion and exclusion criteria . All participants will be given
an outline of the study design and all patient-specific considerations and concerns will be
properly addressed. All participants will be required to provide written informed consent.
All patients enrolled in the study will be further randomly divided into the following two
groups using computer-generated balanced block randomization table with 1:1 allocation
1. Control group - For osseous resection in crown lengthening procedure, conventional
rotary instruments will be used with copious irrigation of sterile saline.
2. Test group-In this group piezoelectric device will be used for osseous resection in
crown lengthening procedure with copious irrigation of sterile saline.
Control Group Before surgical procedure all clinical measurements will be recorded using
customized acrylic stents and radiograph will be taken. Administration of local anesthesia
will be done for nerve block. Incisions will be given based on width of keratinized gingiva.
Before resective surgery, the position of free gingival margins (FGM) will be recorded from
the stent which will be placed on teeth before surgery, using periodontal probe.
Intrasulcular incisions/internal bevel incisions will be given and elevation of full
thickness mucoperiosteal flap will be done in both buccal and lingual aspect. The osseous
resection will be performed based on presence amount of tooth structure to be gained for
future restorative rehabilitation. The ostectomy (removal of bone supporting teeth) will be
performed under combination of rotary instruments, bone chisels, carbide & diamond burs with
copious saline irrigation & maintenance of natural bone anatomy and architecture throughout
the procedure. Exposed root surfaces will be planed to prevent re-attachment and rebounding
of free gingival margins to its initial position. After planning, the surgical sites will be
closed after applying pressure for 3min and providing adaption. Suturing of flap shall be
done based on presence of supracrestal gingival tissues(SGT) acquired postoperatively
,maintaining the preoperative dimensions of the SGT. Fixation of flap then placing apically
to ensure maximum facial & lingual bone coverage. Measurements of parameter will be recorded
by single investigator before and after surgery and post operative instructions will be given
to patients once all procedure is completed. Patients will be recalled after 1week for suture
removal, to evaluate patient morbidity and for demonstration of good oral hygiene. Patients
will be re-evaluated at 3 & 6 months post-operatively.
Test group All surgical procedure will be performed same as described in the control group
except for the use of piezoelectric device for osseous resection used in this group instead
of using conventional rotary instruments with carbide & diamond burs.
All patients will be prescribed an antibiotic, an anti-inflammatory/analgesic and an
antiseptic mouthwash starting from the day of surgery.
PRIMARY OUTCOME
- Postoperative patient perceived outcomes
- Gain in crown length
- Change in alveolar bone level SECONDARY OUTCOME
- Stability of supracrestal gingival tissues
- Surgical time required Clinical parameters- Alginate impression will be made to provide
study casts for full arch fabrication of customized probing stents.The stent will cover
most of the tooth structure but away from gingival margins. The apical edge will be
considered as fixed reference line for probe measurements. The following parameters will
be recorded clinically and radiographically at baseline, 3 & 6months follow up period.
- Gingival index(GI), according to Löe and Silness
- Plaque index(PI), according to Silness and Löe
- Pocket probing depth(PPD)
- Free gingival margin(FGM; measured before surgery and after suturing i.e distance from
stent to free gingival margin)
- Relative attachment level(RAL; measured before and after surgery i.e distance from stent
to base of pocket)
- Bone level via transsulcular probing(BL-TSP; from stent under local anaesthesia before
surgery and after 6months )
- Supracrestal gingival tissues will be measured by SGT=BL-TSP - FGM
- Direct bone level(DBL; before and after osseous resection measured from stent to osseous
crest)
- Flap will be sutured at the level of SGT acquired post operatively.
- Postoperative pain using visual analog scale at treated site (VAS; a scale from 0-10; 0
means no pain/discomfort, 10 means maximum pain/discomfort). at these time point: 1st
day, 4th day and 7th day postoperative.
All patients will be asked to fill the given format which include visual analog scale diagram
ranging from 0-10 point scale.
Radiographic- Intra oral periapical radiographic evaluation of alveolar bone level will be
done at baseline, after surgery and 6 months post-operatively. By taking CEJ (cement enamel
junction) as a fixed reference point to alveolar bone crest, bone level will be measured at
various time periods using image j software. Standardised intraoral periapical radiographs
will be taken by using customized bite block with paralleling angle technique using Rinn XCP
holder.
Data Collection And Methods All the data will be collected from calibrated and standardized
manual periodontal probe (CP-15 UNC SE,Hu Friedy, Chicago IL). Measurements will be made at
six sites on treated tooth(TT;
mid-facial,mid-lingual/palatal,mesio-buccal,mesio-lingual/palatal,disto-buccal,disto-lingual/
palatal)at four sites on adjacent tooth(AT; mesio-buccal, disto-buccal, mesio-lingual &
disto-palatal/lingual)and at eight sites on non adjacent tooth(NA;tooth which is far from
treated tooth;mesio-buccal,mesiobuccal furcation, distobuccal furcation, disto-buccal,
mesio-lingual/palatal, mesio-lingual/palatal furcation, disto-lingual/palatal furcation,
disto-lingual/palatal).
DATA MANAGEMENT AND STATISTICAL ANALYSIS Data recorded will be processed by standard
statistical analysis. The normality of distribution of data will be examined by Shapiro Wilk
test. Statistical analysis will be performed according to distribution of data. If it is in
normal distribution, intra group comparison will be done by repeated ANOVA between different
time points followed by paired T test between two time points and inter group comparison will
be done by using Independent T test between two groups. If it is in non normal distribution,
intra group comparison will be done by Wilcoxon signed rank test and inter group comparison
will be done by Mann-Whitney U test. The Chi square test will be applied to analyze categoric
data. Correlation and association between predictors and dependent variables will be analyzed
by correlation analysis and regression analysis.
