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Minimally Invasive Surgical TechniqueNCT03570736

Evaluation of Gain In Clinical Attachment And Bone Levels After Treatment of Patients With Intra-bony Defects By Minimally Invasive Surgical Technique Versus Open Flap Debridement.

A study testing Minimal invasive surgical technique and Open Flap Debridement in people with Minimally Invasive Surgical Technique and Open Flap Debridement, run by Cairo University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Hypothesis:The conventional surgical approach is to raise large flaps to completely and exceedingly expose the area of interest. Since the results were unsatisfactory due to limited regenerated periodontal tissue, an alternative approach to access the intra-bony defects was proposed, this approach is called minimally… Read more about this study

Who is it for?
Ages 25 years and olderHealthy volunteers can take part
What is being tested?
Minimal invasive surgical technique and Open Flap Debridement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
Jul 2018to Jul 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 25 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 25 years of age or older.
  • At least one periodontal infrabony pocket (detected radiographically) with Probing depth (PD) ≥5 mm,
  • Plaque index < 30 %

Who cannot join

  • Hopeless tooth.
  • Previous periodontal surgery within the last 2 years in area of interest.
  • Systemic conditions which are generally considered to be a contraindication to periodontal surgery which included but not limited to: osteoporosis, uncontrolled diabetes.
  • Pregnant or lactating females
  • Current or former smokers.
  • Non compliant patients

Trial locations and contacts

No sites are listed yet.

Mohamed Gamal Abd El Salam contact

00201122245225

mohamedgamal6491@gmail.com

About this study

Official title: Evaluation of Gain In Clinical Attachment And Bone Levels After Treatment of Patients With Intra-bony Defects By Minimally Invasive Surgical Technique Versus Open Flap Debridement. A Randomized Controlled Clinical Trial

Hypothesis:The conventional surgical approach is to raise large flaps to completely and exceedingly expose the area of interest. Since the results were unsatisfactory due to limited regenerated periodontal tissue, an alternative approach to access the intra-bony defects was proposed, this approach is called minimally invasive techniques which use incisions just large enough for debridement and generally involves reflecting the papilla only using specialized instruments to access the intra-bony defect and debridement.

Aim of the study:Is to evaluate the gain in clinical attachment level and bone after treatment of the intra-bony defects by Minimally Invasive Surgical Technique when compared to Open Flap Debridement in patients with intra-bony defects.

Read more

Study setting:Study will be conducted in the Oral Medicine and Periodontology department, Faculty of Oral and Dental Medicine - Cairo University, Egypt.Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.

Prior to the start of the study each patient will receive initial periodontal therapy consisting of proper oral hygiene instructions and full-mouth scaling and root planing. Six weeks after completion of the initial therapy, a re-evaluation will be performed to confirm that the patients meet all the inclusion criteria for the study.

Evaluation of the patient's oral hygiene and a written consent will be obtained from the patients who will participate in the trial. Blinded periodontist will record the clinical measurements prior to surgery using a periodontal probe.

Prior to surgery, a stent will be fabricated for each site using diagnostic casts and acrylic resin. Each stent will rest on the occlusal surfaces of at least 4 teeth and had a vertical notch marking the facial and lingual position of the intra-bony defect. A periapical radiograph using paralleling technique using extension cone paralleling (XCP) film holder will be performed for each patient to evaluate alveolar bone loss using DIGORA system.

Surgical procedure:The patients will be randomly assigned into two groups; Group A (Control): Patients receiving Open Flap Debridement (OFD). Group B (Test): Patients receiving Minimally Invasive Surgical technique (MIST).

The operator will anesthetize the surgical sites for both groups. For the OFD technique, buccal and lingual intrasulcular incisions will be done extending at least one tooth mesial and distal to the tooth associated with the intrabony defect. Full thickness mucoperiosteal flaps will be reflected to allow access for debridement of the defect.

Surgical debridement will be carried out to remove subgingival plaque, calculus and granulation tissue. The surgical sites will be irrigated with sterile saline. Surgical flaps will be sutured to the pre-surgical level with 5-0 vicryl suture utilizing a vertical mattress suturing technique achieving primary closure.

For the Minimally Invasive Surgical technique, it will be carried out with 2.5 X optical magnification dental loupes. After local anaesthesia, an envelope flap without vertical releasing incisions will be performed. The defect-associated interdental papilla will be accessed either with the simplified papilla preservation flap (SPPF) in narrow interdental spaces or the modified papilla preservation technique (MPPT) in large interdental spaces. In the SPPF, a diagonal incision traced as close as possible to the buccal side of the papilla col will be performed, whereas in the MPPT a horizontal incision traced on the buccal side of the papilla will be done. Intrasulcular incisions will be performed from the interdental side to the buccal and lingual sides of the teeth neighboring the defect; tiny buccal and lingual flaps will be elevated to expose the bone crest.

All incisions will be done using microsurgical ophthalmic blades. Buccal and lingual flaps will be elevated using sharp dissection only. Granulation tissue adherent to the inner surface of flaps will be carefully removed with microscissors to provide full access and visibility to root surfaces. Defect debridement and root planing will be performed with a combination of mini-curettes. Then sutures will be placed using 6-0 vicryl suture.

Postoperative medication:Administration of amoxicillin (500 mg tabs) T.I.D for 7 days), Chlorhexidine rinse (B.I.D for 14 days). Ibuprofen 600 mg tabs 1 every 8h in case of unbearable pain.

Patient self-care instructions: Sutures will be removed 2 weeks post-surgically. Patients will be asked to abstain from mechanical oral hygiene procedures in the surgical area for 2 weeks. After this period, patients will be instructed to continue mechanical tooth brushing again of the treated sites using a soft toothbrush.

The outcomes will be measured at 1 week, 3 and 6 months post-operatively.

Being tested
Minimal invasive surgical technique, Open Flap Debridement

What participants receive

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

  • Minimal invasive surgical techniqueProcedure or surgery

    Minimal Invasive Surgical technique using either Modified Papilla Preservation or Simplified Papilla Preservation Technique.

  • Open Flap DebridementProcedure or surgery

    Buccal and lingual intrasulcular incisions will be done extending at least one tooth mesial and distal to the tooth associated with the intrabony defect. Full thickness mucoperiosteal flaps will be reflected to allow access for debridement of the defect.

Study groups in NCT03570736
Study groupRoleWhat they receive
Minimal Invasive Surgical TechniqueExperimentalNot described
Receives: Procedure: Minimal invasive surgical technique
Open Flap DebridementActive comparatorNot described
Receives: Procedure: Open Flap Debridement

What is being measured

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

  1. Clinical Attachment Level

    It is the distance measured from the cemento-enamel junction (CEJ) to the bottom of the pocket.

    Measured: up to 6 months post-operatively

Secondary outcomes (4)
  1. Probing Depth

    It is the distance measured from the gingival margin to the bottom of the pocket.

    Measured: up to 6 months post-operatively

  2. Gingival Recession

    It is the distance measured from the CEJ to the most apical extension of gingival margin.

    Measured: up to 6 months post-operatively

  3. Post-Operative Pain

    It wil be measured by Visual Analogue Scale (VAS) with numbers from 0 to 10 (0 indicates 'no pain' to 10 which indicates 'worst pain imaginable')

    Measured: up to 1 week post-operatively

  4. Bone Fill

    It will be measured radio-graphically by DIGORA system

    Measured: up to 6 months post-operatively

Timeline

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

  1. First posted27 Jun 2018
  2. Study startJul 2018 (estimated)
  3. Primary completionJul 2019 (estimated)
  4. Study completionJul 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
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03570736
Sponsor's protocol ID
12348765
Status last verified
Jun 2018
First submitted
14 Jun 2018
Last updated
27 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Minimal invasive surgical technique and Open Flap Debridement in people with Minimally Invasive Surgical Technique and Open Flap Debridement, run by Cairo University.

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 3 inclusion and 6 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 2018. Status can change between updates, so confirm with the study contact before making plans.

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 Mohamed Gamal Abd El Salam (00201223467565, Mohamed.gamaleldin@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Attachment Level (time frame: up to 6 months post-operatively). 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 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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