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Intrabony Periodontal DefectPhase 4NCT06048042

Evaluation of Autogenous Demineralized Dentin Graft Vs Autogenous Bone Graft in Management of Intrabony Defects

A Phase 4 study testing Autogenous Demineralized Dentin Graft and Autogenous Bone Graft in people with Intrabony Periodontal Defect, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Intrabony Periodontal Defect
What is being tested?
Autogenous Demineralized Dentin Graft and Autogenous Bone Graft
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteEgypt
Study dates
17 Jul 2024to Mar 2025
Phase
Phase 4
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

  • Patient-related criteria:
  • Motivated patient 18 years of age or order.
  • Patient consulting in the outpatient clinic.
  • Patient ready to perform oral hygiene instructions.
  • Provide informed consent.
  • Accepts the 6 months follow-up period.
Show all 10Show fewer
  • Teeth related criteria:
  • Tooth with two or three-walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
  • Mature permanent tooth.
  • Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or supernumerary tooth to be extracted and used as whole tooth graft inside the intrabony defect.

Who cannot join

  • Patient-related criteria:
  • Medically compromised patients.
  • Pregnant women.
  • Uncooperative patients.
  • Smokers.
  • Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism).
Show all 13Show fewer
  • Failure to maintain good oral hygiene.
  • Teeth related criteria:
  • Teeth with supra-bony defects.
  • Teeth with grade III mobility.
  • Teeth having interproximal craters, grade III furcation involvement, and grade III mobility.
  • Presence of caries or overhanging restorations.
  • Presence of peri-apical injuries.

Trial locations and contacts

1 site in 1 country.

Ghada M. Abouhussein, Bachelor contact

+02 01004966156

ghada.mohammed@dentistry.cu.edu.eg

Nesma Shemais, Ass Lecturer contact

nesma.shemais@dentistry.cu.edu.eg

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

    Cairo

    Recruiting

Other trials in Egypt

About this study

Official title: Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft Versus Autogenous Bone Graft in Management of Periodontal Intrabony Defects Using Modified Minimally Invasive Surgical Technique: A Non-Randomized Clinical Trial

The main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects.

The main question is: In periodontitis patients with intrabony defects, will using autogenous demineralized dentin as bone graft substitute result in clinical attachment gain and linear bone fill similar to autogenous bone graft following modified minimally invasive surgical technique? After enrolment, each participant with intra-bony defects will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any.

Read more

After 4-6 weeks, an individually customized positioning stent will be fabricated for each participant 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.

Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD (Probing depth) ≥ 5 mm, CAL (Clinical attachment loss) ≥ 4 mm.

Surgical procedures will include flap elevation for approaching the defect-associated sites using the modified minimally invasive surgical technique (M-MIST).

Intervention group: The defect will be filled with autogenous demineralized dentin graft prepared from the participant's freshly extracted own teeth.

Control group: The defect will be filled with autogenous bone graft harvested from the retromolar area.

For both groups, flaps will be approximated and sutured at the original position. All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (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 and after 6 months.

Read the detailed description

Research objective: The aim of conducting this research is the development of a newer, less invasive and cost-effective therapeutic approaches that help in management of periodontal intrabony defects. Due to the shortcomings of other bone substitute materials, another bone substitute material that would be completely autogenous and cost-effective is required. Grafting autogenous demineralized dentin has been used extensively for socket preservation and showed promising results in addition to being cost-effective.

Research Procedure in brief:

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:

Patient-related criteria:

  • Motivated patient 18 years of age or order.
  • Patient consulting in the outpatient clinic.
  • Patient ready to perform oral hygiene instructions.
  • Provide informed consent.
  • Accepts the 6 months follow-up period.

Teeth related criteria:

  • Tooth with two or three-walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
  • Mature permanent tooth.
  • Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or supernumerary tooth to be extracted and used as whole tooth graft inside the intrabony defect.

II. Exclusion criteria:

Patient-related criteria:

  • Medically compromised patients.
  • Pregnant women.
  • Uncooperative patients.
  • Smokers.
  • Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism).
  • Failure to maintain good oral hygiene.

Teeth related criteria:

  • Teeth with supra-bony defects.
  • Teeth with grade III mobility.
  • Teeth having interproximal craters, grade III furcation involvement, and grade III mobility.
  • Presence of caries or overhanging restorations.
  • Presence of peri-apical injuries.

General operative procedure:

  • The selected participants will be informed about the nature of the research and its procedures, then written informed consent will be obtained.
  • The surgical procedure will be explained to all patients prior to surgery.
  • Patients diagnosed with periodontitis who meet the inclusion criteria will be screened for periodontal examination. Based on this examination, target sites will be identified.
  • Each patient will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any.

Pre-surgical patient preparation (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.
  • A periapical radiograph using paralleling technique using KCP film holder will be performed for each patient to evaluate alveolar bone loss using DIGORA system.

Surgical procedures

  • Pre-procedural mouth rinse using 0.2% chlorhexidine gluconate3 rinses for intraoral antisepsis.
  • Surgical sites will be anaesthetized using local anesthesia4.
  • The defect-associated inter-dental papilla will be surgically approached either with a diagonal incision following the pattern of the simplified papilla preservation flap when the width of the inter-dental space is 2 mm or narrower or with a horizontal incision according to the modified papilla preservation technique at inter-dental sites wider than 2 mm.
  • Flap elevation will be limited to the buccal flap.
  • No inter-dental and/or lingual intra-sulcular incisions will be performed.
  • After removal of the granulation tissue by careful dissection and root debridement, the root surface will be chemically conditioned with a 2 min. application of an EDTA gel.

The participants will be divided into two groups:

Intervention group:

  • The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique.

Control group:

  • Modified minimally invasive surgical technique (M-MIST) will be performed in the intra-bony defects, with autogenous bone graft 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 placed in the defect.
  • For both groups, flaps will be approximated and sutured at the original position with a 5-0 monofilament polypropylene suture material using simple direct loop interrupted technique.

Post-operative care and follow-up

  • Participants will be instructed to abstain from trauma on the operative site, not to interfere with the suture and to avoid hot food or vigorous rinsing.
  • Tooth brushing will be encouraged for other parts of the dentition and gentle tooth brushing for the operative site will be advised to be resumed after two weeks.
  • Participants will be prescribed Ibuprofen 600 mg.
  • Chlorhexidine 0.12% mouthwash will be prescribed for gentle rinsing twice daily for two weeks.
  • Sutures will be removed two weeks after the surgery.
  • All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (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 and after 6 months.
Being tested
Autogenous Demineralized Dentin Graft, Autogenous Bone Graft
Keywords
Intrabony Periodontal Defect, Demineralized dentin graft, Autogenous bone graft, modified minimally invasive surgical technique, M-MIST

What participants receive

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

  • Autogenous Demineralized Dentin GraftBiological

    The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique.

  • Autogenous Bone GraftBiological

    Modified minimally invasive surgical technique (M-MIST) will be performed in the intra-bony defects, with autogenous bone graft 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 placed in the defect.

Study groups in NCT06048042
Study groupRoleWhat they receive
Autogenous Demineralized Dentin GraftExperimentalAn Autogenous Demineralized Dentin Graft will be prepared from the participant's freshly extracted teeth and placed in the intrabony defect following the modified minimally invasive surgical technique.
Receives: Biological: Autogenous Demineralized Dentin Graft
Autogenous bone GraftActive comparatorAn Autogenous Bone Graft will be harvested from the retromolar area and placed in the intrabony defect following the modified minimally invasive surgical technique.
Receives: Biological: Autogenous Bone Graft

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 6 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, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.

Secondary outcomes (8)
  1. Linear bone fill change from baseline to 6 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, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

  2. Gingival index (GI) change from baseline to 6 months

    The GI will be evaluated by using Silness-Loe GI (0 = Normal gingiva, 1 = Mild inflammation, 2 = Moderate inflammation, 3 = Severe inflammation).

    Measured: GI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

  3. Plaque index (PI) change from baseline to 6 months

    The PI will be evaluated by using Silness-Loe PI (0 = no plaque, 1 = thin film of plaque along the gingival margin, 2 = Moderate accumulation of plaque in the sulcus, 3 = Large amount of plaque in sulcus along the gingival margin).

    Measured: PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

  4. Probing pocket depth (PPD) change from baseline to 6 months

    The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements.

    Measured: PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

  5. Gingival recession (GR) change from baseline to 6 months

    The GR will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin.

    Measured: GR will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

  6. Bleeding on probing (BoP) change from baseline to 6 months

    The BoP will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin.

    Measured: BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

  7. Postoperative Pain

    Postoperative Pain will be measured by using visual analogue score (0-10).

    Measured: Postoperative Pain will be measured after the surgical procedure and 2 weeks post-surgical.

  8. Patient satisfaction

    Patient satisfaction will be measured using a survey.

    Measured: Patient satisfaction will be measured 2 weeks post-surgical.

Timeline

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

  1. First posted21 Sep 2023
  2. Study start17 Jul 2024
  3. Primary completionJan 2025 (estimated)
  4. Study completionMar 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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A non-randomized Clinical Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06048042
Sponsor's protocol ID
ghadashatra123
Status last verified
Aug 2024
First submitted
9 Sep 2023
Last updated
26 Aug 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 Phase 4 study testing Autogenous Demineralized Dentin Graft and Autogenous Bone Graft in people with Intrabony Periodontal Defect, 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 10 inclusion and 13 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 26 Aug 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Ghada M. Abouhussein, Bachelor (+02 01004966156, ghada.mohammed@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 6 months. (time frame: CAL gain will be taken at baseline, 1 month, 3 months and 6 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 26 Aug 2024.

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