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Gingival Papillary BluntingNCT03429764

Effect of Different Suturing Technique on Height of Interdental Papilla and Periodontal Healing

A study testing CISS and VIMS in people with Gingival Papillary Blunting, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Papillary Blunting
What is being tested?
CISS and VIMS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteIndia
Study dates
1 Dec 2017to Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient with age 18-65 years and who are systemically healthy.
  • Possessing ≥20 natural teeth
  • Patient with chronic periodontitis ( armitage classification)36
  • Pocket depth ≥ 5mm in maxillary esthetic zone
  • Completed etiological periodontal therapy (oral hygiene instructions and scaling and root planning with full-mouth bleeding score FMBS <20% and plaque index score<1 (sillness n loe)37

Who cannot join

  • Smokers (current and past) and tobacco chewers.
  • Medically compromised patients.
  • Patient on long term use of drugs which could affect the treatment and final outcome of the surgery.
  • Patient under systemic antibiotics in past 6 month.
  • Pregnant women and lactating mothers.
  • Patient who had undergone periodontal treatment 6 months prior to the study.
  • Patients who are allergic to materials or drugs used in study.
  • Patients having loss of contact point in adjacent teeth

Trial locations and contacts

1 site in 1 country.

Nishi Tanwar, MDS contact

8368126310

nsh_tanwar@yahoo.co.in

India1 site, 1 recruiting
  • Post Graduate Institute of Dental Sciences

    Rohtak, Haryana, 124001

    NISHI TANWAR, MDS, 8368126310, nsh_tanwar@yahoo.co.in

    Recruiting

Other trials in India

About this study

Official title: Comparative Clinical Evaluation of Internal Mattress Sutures vs Continuous Independent Sling Sutures on Interdental Papilla Height and Periodontal Healing in Esthetic Zone: Randomized Clinical Study

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.

Read the detailed 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.

Being tested
CISS, VIMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CISSProcedure or surgery

    continuous independent sling sutures will be placed with minimum two intact contact points at the surgical site

  • VIMSProcedure or surgery

    internal mattress suture will be placed with minimum two intact contact points at the surgical site

Study groups in NCT03429764
Study groupRoleWhat they receive
Control group (CG),CISSActive comparatorcontinuous independent sling sutures (CISS) will be placed with minimum two intact contact points at the surgical site,
Receives: Procedure: CISS
Test group (TG),VIMSExperimentalinternal mattress suture (VIMS) will be placed with minimum two intact contact points at the surgical site,
Receives: Procedure: VIMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. inerdental papilla height

    effect on interdental papilla height,

    Measured: 6 months

  2. CAL

    Gain in clinical attachment level

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2018
  2. Study start1 Dec 2017
  3. Primary completionFeb 2019 (estimated)
  4. Study completionFeb 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03429764
Sponsor's protocol ID
Rashmiperio
Status last verified
Jan 2018
First submitted
30 Jan 2018
Last updated
12 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CISS and VIMS in people with Gingival Papillary Blunting, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nishi Tanwar, MDS (8368126310, nsh_tanwar@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

inerdental papilla height (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.

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