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Isolated Intrabony Periodontal Defects in Patients With PeriodontitisNCT06347263

Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects

A study testing Entire papilla preservation technique in people with Isolated Intrabony Periodontal Defects in Patients With Periodontitis, run by Cairo University at 1 site in Egypt.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Entire papilla preservation technique
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteEgypt
Study dates
12 Apr 2024to 30 Apr 2025
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients with healthy systemic condition.
  • Adult patients (18 years old and older).
  • Patients with stage lll periodontitis, having one isolated intrabony defect with probing depth >6mm, clinical attachment level> 6mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth.
  • Patients with full mouth plaque score<20%.
  • Patients with full mouth bleeding score<20%.
  • Compliance with good oral hygiene.
  • Patients accept 6-months follow-up period (cooperative patients).
  • Patients provide an informed consent.

Who cannot join

  • Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
  • One wall intrabony defect.
  • Defects that involve the buccal and lingual sites.
  • Smokers ˃ 10 cigarettes / day.
  • Pregnant and lactating females.

Trial locations and contacts

1 site in 1 country.

Laila T Sedeek, Bachelor contact

01223685495

laila.taher@dentistry.cu.edu.eg

Nesma M Shemais, Ass Lecturer contact

nesma.shemais@dentistry.cu.edu.eg

Egypt1 site, 1 recruiting
  • Faculty of dentistry, Cairo University

    Cairo, 3753450

    Nesma M Shemias, Ass Lecturer, nesma.shemais@dentistry.cu.edu.eg

    Manal M Hosny, Professor, manal.hosny@dentistry.cu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects: A Randomized Clinical Tria

The goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis.

Read the detailed description

Research objective: The aim of conducting this research is the development of a newer, less invasive and cost-effective surgical approaches that help in treatment of periodontal intrabony defects.Due to the shortcomings of access flap approaches , another minimally invasive surgical technique which is the Entire papilla preservation technique will be used to approach the defect .Also, due to the short comings of using other bone substitute materials and resorbable membranes , the Autogenous bone graft which is the gold standard of bone grafts and the injectable platelet rich fibrin will be used in this study .

Research Procedure in brief:

The study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University, Egypt. This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University.

Eligibility criteria:

  1. Inclusion criteria:
  2. Patients with healthy systemic condition.
  3. Adult patients (18 years old and older).
  4. Patients with stage lll periodontitis, having one isolated intrabony defect with probing depth >6 mm, clinical attachment level> 6 mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth.
  5. Patients with full mouth plaque score<20%.
  6. Patients with full mouth bleeding score<20%.
  7. Compliance with good oral hygiene.
  8. Patients accept 6-months follow-up period (cooperative patients).
  9. Patients provide an informed consent.

II. Exclusion criteria:

  1. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
  2. One wall intrabony defect.
  3. Defects that involve the buccal and lingual sites.
  4. Smokers ˃ 10 cigarettes / day.
  5. Pregnant and lactating females.

General operative procedures:

1.Preoperative preparation:

Clinical examination:

Each patient will be examined to confirm that he/she met the eligibility criteria. This is followed by:

  1. Full mouth charting to evaluate the periodontal status will be performed by using UNC 15 periodontal probe, including assessment of plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession, and radiographic x-ray imaging.
  2. Patients will be thoroughly informed on self-performed plaque control activities consisting of using the modified Bass brushing technique, a soft toothbrush, regular toothpaste twice a day, and inter-dental cleaning once a day.
  3. The patients will receive supra gingival scaling with ultrasonic scaler, then they will be recalled after 2 weeks. 4_An oral hygiene session will be performed two weeks before the surgical treatments.

Each patient will be prescribed a 0.2% chlorhexidine-based mouthwash, twice a day, for two weeks. Clinical photographs: Clinical photographs will be taken at baseline and at 12 months postoperatively. Radiographic examination: Periapical radiographs using paralleling technique using KCP film holder will be performed for each patient on the defect site to evaluate alveolar bone loss using DIGORA system.

Initial Therapy:

The initial therapy will consist of periodontal treatment (phase I therapy) including supra gingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.

Re-evaluation phase:

  • 4-6 weeks after the initial therapy, periodontal re-evaluation will be done to confirm the sites that will require surgical therapy.
  • Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD ≥ 5 mm, CAL ≥ 4 mm.
  • An individually customized positioning stent will be fabricated for each patient and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements.

Surgical procedures

  • Pre-procedural mouth rinse using 0.2% chlorhexidine gluconate3 rinses for intraoral antisepsis.
  • Surgical sites will be anaesthetized using local anesthesia.
  • Following a buccal intra-crevicular incision, a bevelled vertical releasing incision will be performed in the buccal gingiva of the neighbouring inter-dental space and extended just beyond the mucogingival line( The Entire papilla preservation technique_EPPT)to provide adequate mechanical access to the intra-bony defect. A microsurgical periosteal elevator will be used to elevate a buccal full-thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla.
  • The inter-dental papilla will be elevated in full-thickness manner up to the intact lingual bone crest.
  • A microsurgical scissor and mini curettes will be used to remove the granulation tissue from the inner aspect of the defect-associated inter-dental papilla.
  • Any residual subgingival plaque or calculus will be gently removed from the exposed root surface with an ultrasonic scaler.
  • The surgical site will be thoroughly rinsed with sterile saline.

The participants will be divided into two groups:

Intervention group:

  • The Entire papilla preservation surgical technique (EPPT) will be performed to approach the intra-bony defects, with autogenous bone graft mixed with injectable platelet rich fibrin (I-PRF) placement. The graft will be harvested from the retromolar area using automatic chip maker (ACM) bur and a hand bone mill will be used to grind the chips into particles, then it will be mixed with I-PRF and placed in the defect.
  • I-PRF will be prepared as follows:(Choukroun et al., 2018) 10 ml of peripheral venous blood will be collected into a sterile 10 ml plastic PRF tube (to reduce clotting time) without anticoagulants and centrifuged immediately at room temperature using centrifugal force 700 rpm for 3 minutes (60gRCF), then the yellow fluid (liquid fibrinogen) at the top of the tubes will be aspirated with a blunt sterile syringe, avoiding red blood cells.

Control group:

  • The Entire papilla preservation surgical technique (EPPT) will be performed to approach the intra-bony defects without autogenous bone graft and Injectable platelet rich fibrin placement.
  • For both groups, flaps will be approximated and sutured at the original position with a 5-0 or 6_0 monofilament polypropylene suture material. Postoperative Care
  • Participants will be given instructions to avoid any trauma to the surgical site, refrain from interfering with the sutures, and to avoid consuming hot food or engaging in vigorous rinsing.
  • They will be advised to continue tooth brushing for the other parts of their dentition, while gentle tooth brushing for the surgical site will be advised to be resumed after a two-week period.
  • The patients will be requested to rinse gently with 0.12% chlorhexidine digluconate mouth rinse for 1 minute twice daily for a duration of two weeks.
  • Participants will be prescribed either Amoxicillin 500 mg (Misr Co. for Pharmaceutical Industries, Egypt) three times daily for five days, or doxycycline 100mg (Doxycycline, Nile Co. for Pharmaceuticals and Chemical Industries, Egypt) twice daily if they have allergy to penicillin.
  • Sutures will be removed two weeks after the surgery.
  • All the subjects will be evaluated at 1, 3, 6 and 12 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachmentlevel (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months, 6 months and after 12 months.
Being tested
Entire papilla preservation technique
Keywords
Periodontal intrabony defects, Entire papilla preservation technique, EPPT, Injectable platelet rich fibrin, I-PRF

What participants receive

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

  • Entire papilla preservation techniqueOther

    Minimally invasive periodontal surgery

Study groups in NCT06347263
Study groupRoleWhat they receive
Test groupExperimentalProcedure:Entire papilla preservation technique with autogenous bone and injectable platelet rich fibrin
Receives: Other: Entire papilla preservation technique
Control groupActive comparatorProcedure: Entire papilla preservation technique alone.
Receives: Other: Entire papilla preservation technique

What is being measured

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

  1. Clinical attachment level (CAL) gain change from baseline to 12 months

    The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements.

    Measured: CAL gain will be taken at baseline, 3 month, 6 months and 12 months after the intervention during the follow-up period and will be done by a single calibrated examiner.]

Secondary outcomes (1)
  1. Linear bone fill change from baseline to 12 months

    Linear bone fill will be radiographically measured from the CEJ to the deepest part of the intrabony defect using the linear measurement tool of the Digora software. Individually customized positioning stent will be fabricated for each patient and parallel-angle technique will be employed using X-ray film holding system. This will ensure accuracy and reproducibility of the measurements. Radiographic linear defect depth (RLDD) will be measured as the depth of the intrabony defect from the alveolar crest to the defect base at baseline and 6 months postoperatively. The defect angle will be measured at baseline, as the angle formed between intersections of lines from the alveolar crest to the defect base and tooth long axis line. Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values, and percentages of bone fill will be expressed as the proportion of change to baseline RLDD.

    Measured: Linear bone fill will be measured at baseline, 6 months and 12 months after the intervention during the follow-up period and will be done by a single calibrated examiner]

Timeline

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

  1. First posted4 Apr 2024
  2. Study start12 Apr 2024
  3. Primary completionApr 2025 (estimated)
  4. Study completion30 Apr 2025 (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
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06347263
Sponsor's protocol ID
PER 332
Status last verified
Jul 2024
First submitted
29 Mar 2024
Last updated
5 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Entire papilla preservation technique in people with Isolated Intrabony Periodontal Defects in Patients With Periodontitis, run by Cairo University at 1 site in Egypt.

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 8 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 5 Jul 2024. 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 Egypt. 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 Laila T Sedeek, Bachelor (01223685495, laila.taher@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 (CAL) gain change from baseline to 12 months (time frame: CAL gain will be taken at baseline, 3 month, 6 months and 12 months after the intervention during the follow-up period and will be done by a single calibrated examiner.]). 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 5 Jul 2024.

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