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PeriodontitisNCT05696600

Impact of Supracrestal Tissue Attachment Dimension on Outcome of Scaling and Root Planing and Open Flap Debridement Procedure in Different Periodontal Phenotypes

A study testing Scaling and root planing and open flap debridement in people with Periodontitis, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The existence of supracrestal tissue attachment (SCTA) is fundamental for adhesion of the junctional epithelium and insertion of the connective fibers to the dental structure, besides functioning as a barrier against microbial entry in the periodontium. Read more about this study

Who is it for?
Ages 30 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis
What is being tested?
Scaling and root planing and open flap debridement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteIndia
Study dates
1 Feb 2023to 31 Mar 2024
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 30 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients with generalised stage II or stage III periodontitis
  • Maxillary or mandibular incisors having same periodontal phenotype

Who cannot join

  • Patient with systemic diseases like uncontrolled diabetes, hypertension, bleeding disorders, coronary artery disease etc.
  • Malaligned teeth
  • Patient having undergone any periodontal therapy within one year
  • Pregnant and lactating females
  • Patient on antibiotic therapy in the past one month

Trial locations and contacts

1 site in 1 country.

Rajinder Kr Sharma, MDS contact

9416358222

rksharmamds@yahoo.in

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

    Rohtak, Haryana, 124001

    Recruiting

Other trials in India

About this study

Official title: "Impact of Supracrestal Tissue Attachment Dimension on the Outcome of Scaling and Root Planing and Open Flap Debridement Procedure in Patients With Stage II and Stage III Periodontitis in Thin Versus Thick Periodontal Phenotype: A Comparative Interventional Study"

The existence of supracrestal tissue attachment (SCTA) is fundamental for adhesion of the junctional epithelium and insertion of the connective fibers to the dental structure, besides functioning as a barrier against microbial entry in the periodontium. Wide variation in SCTA dimension have been reported in patients with and without periodontitis. If the physiologic dimension of SCTA is violated then it may lead to inflammation in periodontium. Influence of dimension of SCTA on scaling and root planning and open flap debridement procedure has not been investigated till date. Thus the aim of study is to assess the influence of SCTA dimension on the outcome of scaling and root planning followed by open flap debridement in patients with stage 2 and stage 3 periodontitis and also to estimate the SCTA dimension in thick versus thin periodontal phenotype.

Read the detailed description

Periodontitis is defined as an inflammatory disease of supporting tissues of teeth caused by specific microorganisms or groups of specific microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone with periodontal pocket formation, gingival recession or both 1. Its severe form affects 11% of the population worldwide 2. Periodontitis influence oral health related quality of life (OHRQoL) and thus is a major public health problem3. Treatment of periodontal disease includes non-surgical and surgical procedures. Reduction in pocket depth and gain in clinical attachment level are usually considered as successful outcomes of periodontal therapy. While Non-surgical therapy is effective in shallow pockets, significant gain of clinical attachment is usually observed in deep pockets after surgical therapy 4.

There are various surgical procedures for the management of periodontal pocket which include curettage, gingivectomy, periodontal flap surgery and guided tissue regeneration. Among these, periodontal flap surgery is used widely. The primary objective of periodontal flap surgery is to obtain access for root instrumentation so that plaque can be removed and the secondary objective is pocket reduction via soft and hard tissue resection to facilitate home care5. Neumann was the pioneer of periodontal flap6 surgery then Widman described the different incision technique for periodontal flap in 1966. A modification of Widman flap was described by Ramfjord and Nissle in 19747. This modification includes initial incision which is parallel to the long axis to the tooth and a second crevicular incision which surrounds the neck of teeth. Advantages of modified Widman flap surgery are that it conserves bone and there is optimal root coverage which is esthetically acceptable and also permits oral hygiene. It also results in more pocket closure and more bone regeneration. But one of the major disadvantage of modified Widman flap procedure is unfavourable interproximal architecture immediately after removal of dressing7.

With time it has been seen that outcomes of surgical periodontal therapy is effectively influenced by various factors such as pocket depth, severity of gingival inflammation, marginal alveolar bone, systemic diseases and smoking8-10. As per the literature available these factors need to be further explored. Biologic width, which is now known as supracrestal tissue attachment (SCTA) is described as a variable entity comprising of junctional epithelium and connective tissue attachment coronal to the alveolar crest11. A landmark histologic study by Gargiulo et al which was done on human autopsy specimens has given an average of 2.04 mm for this entity12, though a study by Vacek et al stated that it may range from 0.75 mm to as large as 4 mm in a healthy periodontium13. But these studies did not tell about the clinical significance of BW and then Inger et al were the first to describe the clinical significance of biological width in dentistry. Another human histometric study has demonstrated mean measurement of supracrestal tissue as 2.75+/-0.59mm. however these studies were only conducted on healthy periodontium14. Only a few studies have attempted to assess the dimensions of SCTA in periodontal disease. According to a study by Novak et al, average clinical biologic width in case of severe, generalized, chronic periodontitis was observed to be nearly twice as previously reported for histological width which was 2.04mm (1.94 -1.97mm). In this study 44% of all measured sites were had PD and CAL less than equal to 3mm. Its observations suggested that even in the presence of a severe, generalized, horizontal pattern of alveolar bone loss, nearly half of the clinical sites in the mouth showed minimal clinical signs of disease but extensive radiographic evidence of alveolar bone loss15. One of the study by Abullais et al suggest that clinical and radiographic findings of the SCTA showed a significant difference in patients with periodontitis16. Various clinical and experimental studies are available in the literature about the effect of periodontal surgical procedure on healing and regeneration of SCTA but there is no study in the literature which demonstrate the effect of SCTA on scaling and root planning and open flap debridement. Thus, the aim of this study is to evaluate the impact of supracrestal tissue attachment dimension on the outcomes of scaling and root planing followed by open flap debridement in patients with stage 2 and stage 3 periodontitis between thick versus thin periodontal phenotypes.

MATERIALS AND METHODOLOGY

SETTINGS: The present prospective clinical trial will be conducted in the Department of Periodontics, Post Graduate Institute of Dental Sciences, Rohtak STUDY DESIGN: Interventional study TIME FRAME: 12-14 months SAMPLE SIZE Sample size determination was done by using G power software. Results of a previous study by Gumber et al. taking changes in clinical attachment gain as the clinical outcome at the end of 6 months between thick and thin PP was used to compute the effect size, taking power as 80% and α as 0.05. Sample of 18 patients per group was calculated as the minimum sample size for the study. Considering 30% patient attrition, a total of 24 patients will be recruited per group.

METHOD OF RECRUITMENT:

Patients will be recruited from out patient clinic of Department of Periodontics, PGIDS, Rohtak after screening based on given inclusion and exclusion criteria.

RANDOMIZATION \& ALLOCATION CONCEALMENT-Not applicable BLINDING/MASKING-single blind INTERVENTION All the participants will undergo phase-I therapy with a combination of hand scalers and curettes (Hu Friedy) and ultrasonic scaler (EMS Piezon,250, Switzerland). Oral hygiene instructions will be imparted and will be reinforced at each appointment.

After a period of 6 weeks of scaling and root planing, patients having residual probing depth of ≥ 5 mm at ≥ 4 sites along ≥ 2 maxillary or mandibular incisors teeth will be recalled for open flap debridement. Patients will be recalled at the end of 3 months and 6 months for recording of parameters.

METHODOLOGY:

Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining the informed consent. Periodontal parameters will be assessed which include Plaque index (PI), Gingival index (GI), clinical attachment level (CAL) , periodontal pocket depth (PPD), bleeding on probing (BOP), Periodontal phenotype (PP), keratinized tissue width (KTW) and supracrestal tissue attachment (SCTA).

KTW will be evaluated before supracrestal tissue attachment (SCTA) measurement and SCTA will be measured under local anesthesia.

The transgingival probing depth will be measured till the alveolar crest (from the free gingival margin to the alveolar crest under LA). SCTA will be obtained after subtracting the probing depth (free gingival margin to base of the periodontal pocket) from supracrestal gingiva.

Evaluation of PP will be done after completion of Phase I therapy using probe transparency method.

Conditions
Periodontitis
Being tested
Scaling and root planing and open flap debridement
Medical subject headings
Periodontitis

What participants receive

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

  • Scaling and root planing and open flap debridementProcedure or surgery

    Scaling and root planing involves removal of plaque and calculus.

    Open Flap debridement involves reflection of full thickness mucoperiosteal flap, thorough debridement of the surgical site and approximation and suturing of the flap at the original position.

Study groups in NCT05696600
Study groupRoleWhat they receive
Thick periodontal phenotypeExperimentalScaling and root planing and open flap debridement in patients with stage II and stage III periodontitis
Receives: Procedure: Scaling and root planing and open flap debridement
Thin periodontal phenotypeActive comparatorScaling and root planing and open flap debridement in patients with stage II and stage III periodontitis
Receives: Procedure: Scaling and root planing and open flap debridement

What is being measured

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

  1. CLINICAL ATTACHMENT LEVEL (CAL)

    Clinical Attachment Level will be measured as the distance between the base of the clinical pocket and the cemento-enamel junction(CEJ).Measurements will be made at 6 sites of involved tooth- mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto- lingual using UNC-15 probe.

    Measured: 6 MONTHS

  2. BLEEDING ON PROBING (BOP)

    BOP will be recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100. It will be designed as % sites with bleeding on probing.

    Measured: 6 MONTHS

  3. PROBING POCKET DEPTH (PPD)

    Probing pocket depth will be measured as the distance from the gingival margin to the base of the clinical pocket. The probing depth measurements will be assessed using a calibrated manual periodontal probe (PCP-UNC 15 Hu-Friedy, Chicago, IL, USA). The probe will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of involved tooth - mesio-buccal, mid-buccal, disto-buccal, mesio- lingual, mid-lingual, disto-lingual. Measurements will be rounded to the nearest whole millimetre.

    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 posted25 Jan 2023
  2. Study start1 Feb 2023
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion31 Mar 2024 (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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696600
Sponsor's protocol ID
SAKSHIPERIO
Status last verified
Jun 2023
First submitted
13 Jan 2023
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Scaling and root planing and open flap debridement in people with Periodontitis, 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 2 inclusion and 5 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 27 Jun 2023. 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 Rajinder Kr Sharma, MDS (9416358222, rksharmamds@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CLINICAL ATTACHMENT LEVEL (CAL) (time frame: 6 MONTHS). The study lists 3 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 27 Jun 2023.

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