Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03429764 |
| Other study ID # |
Rashmiperio |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
January 30, 2018 |
| Last updated |
February 9, 2018 |
| Start date |
December 1, 2017 |
| Est. completion date |
February 2019 |
Study information
| Verified date |
January 2018 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
Nishi Tanwar, MDS |
| Phone |
8368126310 |
| Email |
nsh_tanwar[@]yahoo.co.in |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Comparative clinical evaluation of internal mattress sutures vs continuous independent sling
sutures on interdental papilla height and periodontal healing in esthetic zone.
To evaluate the effect of internal mattress suturing technique on interdental papilla height
and periodontal healing after periodontal surgery in esthetic zone.
To evaluate the effect of continuous independent sling suturing technique on interdental
papilla height and periodontal healing after periodontal surgery in esthetic zone.
Description:
In the last decade, esthetics has become a major concern in the periodontal therapy. Modern
aesthetic dentistry involves not only the restoration of lost teeth, but increasingly the
management and reconstruction of the encasing gingiva. Interdental papilla not only acts as a
biological barrier in protecting the periodontal structures but also plays a critical role in
aesthetics. Numerous risk factors lead to the development of open gingival embrasures or
black triangle. These factors include periodontal disease, length of embrasure area, root
angulations, interproximal contact position, triangular shape crowns, and consequence of post
periodontal surgery.
Interproximal soft tissue craters formation are the consequences of periodontal surgeries
like modified widman flap procedures, osseous surgery. Study shows higher percentage of
interproximal soft tissue craters in modified widman flap surgery as compared to osseous
surgery at six weeks. This creates difficulty for the therapist and patients in performance
and plaque control procedures, leading to persistent soft tissue inflammation and black
triangle formation.
Primary closure of interdental area is technically more demanding. In periodontal surgery,
the most common method of wound closure uses sutures. The primary objectives of suturing are
to stabilize and to secure tissues in their desired locations. Therefore choosing an
appropriate suturing technique, thread type, thread diameter and surgical needle as well as
using proper surgical knot for each thread material are also critical.
Proper management of supracrestal soft tissue flap along with interdental papilla during
suturing appears to be of critical importance in ultimate outcome of surgical periodontal
pocket management. Wound healing after periodontal flap surgery is achieved through four
precisely and highly programmed phases; hemostasis, inflammation, proliferation and
remodelling. Wound stability and undisturbed maturation of a fibrin clot adhering to root
surface is one of the prerequisite for optimum periodontal regeneration. Wound stability is
achieved by close approximation of wound margins for primary intention healing by proper
suturing. Wound integrity during the early healing phase rest primarily on the stabilization
of the gingival flaps offered by suturing with primary closure of the wound edges
inter-proximally while being maintained in maximum passive contact with the root to minimize
the intervening blood clot and to prevent wound contamination Mattress sutures are used for
greater flap security and control. They permit more precise flap placement, especially when
combined with periosteal stabilization. They also allow for good papillary stabilization and
placement. These mattress sutures can be internal or external. The internal mattress sutures
are used when it is desirable to have the papilla position more upright in the embrasure
space. Literature suggests that these sutures may be used in the anterior region when
esthetics ideally required that the papilla fill the entire interdental area Continuous
independent sling suture are used when multiple teeth are involved, provides greater
distribution of forces on the flaps, minimize need for multiple knots, and allow independent
placement of buccal and lingual flaps and permits precise flap placement and also secure
multiple interproximal papillae of one flap independently of the other flap.
Thus the most suitable suturing technique to achieve healing by primary intention and
connective tissue reattachment/ periodontal regeneration and preservation of interdental soft
tissue needs to be explored.
Review of the available literature does not reveal studies conducted to evaluate the effect
of vertical mattress suture technique and Continuous independent sling suturing techniques on
maintaining the height of interdental papilla and periodontal wound healing.
Considering the above mentioned suture technique to be best for primary closure and
regeneration as well as maintaining the supracrestal tissue at the desired location, the
present study is intended to determine the influence of internal mattress suture and
continuous independent sling suture on height of interdental papilla and periodontal healing
in the esthetic zone.
MATERIALS AND METHODS
SUBJECT POPULATION
Participants for the study will be selected from Outpatient Department Of Periodontology And
Oral Implantology at, Post Graduate Institute of Dental sciences (PGIDS), Rohtak.
STUDY POPULATION AND DESIGN
The study population will consist of minimum of 40 systemically healthy patients aged 18 to
65 years with chronic periodontitis, pocket depth ≥ 5 mm after completed etiological
periodontal therapy, requiring open flap debridement in maxillary esthetic zone.
Patients will be randomized in to two groups (minimum 20 each) i.e test and control group.
1. Control group (CG) -continuous independent sling sutures will be placed with minimum two
intact contact points at the surgical site.
2. Test group (TG) -- internal mattress suture will be placed with minimum two intact
contact points at the surgical site.
All potential participants would be explained the need and design of the study. Only those
participant who consented for the study will be included after obtaining written and verbal
informed consent.
METHODOLOGY
Patient will be randomly allocated to control and test groups. The study will be conducted as
follows-
PRESURGICAL THERAPY
Phase 1 therapy-Oral hygiene instruction, patient education and motivation. Full mouth
supragingival and subgingival scaling and root planning with ultrasonic scaler (EMS Piezon
250, Switzerland), hand scaler and curettes (Hu-Friedy) will be completed. Patient will be
re-evaluated for periodontal condition after 6 weeks of phase 1 therapy. Sites with probing
depth ≥5 mm will be treated with periodontal surgery. Patient with good oral hygiene standard
(plaque index score <1 and low level of residual infection (full mouth bleeding score FMBS
<20%) will be considered for periodontal surgery.
PERIODONTAL SURGICAL PROCEDURE
After administration of local anaesthesia, open flap debridement will be done on both control
group and test group. Test group patients vertical internal mattress suture will be placed
and continuous independent sling suture will be placed in control group.
In internal mattress suture, the suture enters the facial tissue just apical to the base of
the papilla, runs across the top of alveolar crest, and penetrates the lingual tissue from
the inside-out apical to the base of the lingual papilla. The suture passes back through the
lingual papilla from the outside-in, 2 to 3 mm coronal to the previous point of suture
penetration, and courses back across the alveolar crest exiting through the facial papilla
from the inside-out at a point 2 to 3 mm coronal to the initial facial entry point. The
facial and lingual papillae are positioned together and the suture is tied on the facial.
In continuous independent sling suture, the suture is passed through the most anterior facial
papilla from outside -in just coronal to the mucogingival junction and looped around the
lingual of tooth to engage the next facial papilla. The suture does not enter the lingual
flap at this time. The suture is looped around each successive tooth, penetrating the facial
papilla just coronal to the mucogingival junction.At distal end of flap, the suture is passed
through facial tissue and looped back around the lingual of terminal tooth and through the
interdental area mesial to the terminal tooth. The suture is then slung around the facial
surface of the terminal tooth towards the distal aspect of lingual flap. Wrapping the suture
around the terminal tooth in this fashion allows facial flap to be locked in placed and
positioned independently of the lingual or palatal flap. The suture is then looped back
around the facial surface of terminal tooth. The suture is passed through the interdental
area to engage next papilla on the lingual or palatal flap. The lingual flap is sutured in a
similar manner as the facial flap. The suture is tied anteriorly where the suture was
initially introduced into the facial tissue.
POST OPERATIVE CARE
Patient will be given both verbal and written instructions about post operative care. He/she
will be advised:
To take antibiotic Amoxycillin 500mg 8 hourly for 5 days along with Ibuprofen 400 mg 8 hourly
for two days.
Sutures will be removed after 1 week.
CLINICAL PARAMETERS
Full mouth indices to be recorded at baseline and follow up.
Probing pocket depth.
Clinical attachment loss.
Bleeding on probing
Site Specific(baseline on the day of surgery) indices
Plaque index (Silness&Loe)
Gingival index (Loe&Silness)
Pocket probing depth
Clinical attachment loss- measured as a distance from cement-enamel junction to the base of
pocket.
Bleeding on probing
Location of crest of free gingival margin in respect to CEJ.
Height of interdental papilla
RADIOGRAPHIC PARAMETER
Intraoral periapical radiographs will be taken for diagnostic purpos PPD and CAL will be
measured using UNC 15 periodontal probe at six sites (mesiobuccal, distobuccal, mesiolingual,
distolingual, and median points at buccal and lingual aspect).
GI, PI will be measured using UNC 15 periodontal probe at four sites(distobuccal,
mesiobuccal, facial, lingual gingival margin)
Papillary height will be measured
1. apical aspect of contact point to tip of papilla and
2. from tip of papilla to the mucogingival junction.
The photographs of interdental papilla will be taken and linear measurements as mentioned
above will be done on the photographs with the help of Image J software.
Clinical parameters will be recorded at enrolment, baseline, 3 months, and 6 months of
periodontal surgery. Interdental papilla height will also be measured at 3 weeks of
periodontal surgery. The patients will be reinforced with oral hygiene instructions at every
visit.
