Clinical trial NCT06569264: Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation
Official title: Clinical and Radiographic Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Socket Preservation
Keywords: Socket preservation
Ridge preservation
Demineralized autogenous dentin graft
i-PRF
vitamin C
ascorbic acid
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The aim of the study is to clinically and radio graphically evaluate marginal bone loss following autogenous demineralized dentin graft (ADDG) and i-PRF addition with and without vitamin C (AA) for post extraction socket preservation.

The main question is:

In patient with non-restorable teeth, does adding vitamin C to dentin graft and i-PRF affect the marginal bone loss of post extraction sockets?

Intervention group:

Alveolar ridge preservation using vitamin C (AA) with autogenous demineralized dentin graft combined with i-PRF.

Adding vitamin C to dentin graft and i-PRF might aid in reducing the dimensional changes and marginal bone loss, since it increases osteoblast proliferation and viability during socket preservation. Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C. By adding vitamin C to i-PRF we can add the advantages of improving soft tissue quality as well.

Control group:

Alveolar ridge preservation using autogenous demineralized denting graft combined with i-PRF. Dentin particle can be used as an excellent autogenous graft material to replace other autogenous graft materials, it can be used in socket preservation. as it enhances bone formation, and has shown an ability to maintain the alveolar ridge dimensions because of its osteo-conductive properties. Moreover, dentin graft is used as a cost-effective grafting material during socket preservation.

The initial therapy consists of periodontal treatment (phase I therapy) including supragingival 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. Flapless and atraumatic tooth extraction will be initiated, Then the sockets will be carefully packed with the allocated graft material that are shaped to match the individual size and contours of each socket. Once the grafts are properly adapted to the sockets, they will be covered with the corresponding graft material, and an absorbable gelatin sponge (gelfoam) will be used for socket and graft material coverage and secured using an internal crisscross knot using 5-0 monofilament polypropylene suture material.

Detailed description: Research objective:

Socket preservation is one of the techniques utilized to maintain bone dimension and minimized post-extraction dimensional changes. Adding vitamin C to dentin graft and i-PRF might aid in reducing the dimensional changes and marginal bone loss, since it increases osteoblast proliferation and viability during socket preservation. By adding vitamin C with i-PRF we can add the advantages of improving soft tissue quality as well. Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C. Moreover, dentin graft is used as a cost-effective grafting material during socket preservation.

l. Inclusion criteria:

* ≥ 18 years of age.
* Single extraction of non-molar teeth with periodontally healthy adjacent teeth.
* Non-contributory medial history.
* Non- restorable teeth indicated for extraction.
* Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
* Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological psychological factors - time related factors).
* Cooperative patients who are willing to commit for 6 months follow up.

II. Exclusion criteria:

* Pregnant female.
* Acute infection at extraction site.
* Systemic conditions affecting healing (e.g., diabetes, medications as bisphosphonates...)
* A participant who had radiotherapy or chemotherapy.
* Psychiatric patient, or with a learning disability, or unable to give consent.

Research Procedure in brief:

The study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, clinic of the department of Oral surgery and clinic of the department of Endodontics -Cairo University. The initial therapy consists of periodontal treatment (phase I therapy) including supragingival 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. Rinsing with 0.12% chlorhexidine will be instructed.

In both groups, tooth extraction under local anesthesia with articaine HCL 2%, 1:20,000 epinephrine will be performed. Flapless minimally traumatic extraction will be done using thin periotomes and luxators. After thorough mechanical cleaning, the sockets will be rinsed with 5 ml of an aqueous 0.125% chlorhexidine digluconate solution, followed by a 5 ml sterile saline rinse to remove tissue debris from the socket. This procedure will be repeated three times for each socket. Followed by inspection of extraction socket integrity, using a William's graduated periodontal probe. Then, extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries or restorations (if present), using a high-speed fine finishing stone and saline irrigation. The pulp chamber will be cleaned with sterile endodontic files. Subsequently, teeth will be ground, using hand bone mill.

The demineralized autogenous tooth graft (ADDG) particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze.

For i-PRF preparation, blood will be withdrawn in plastic tubes without anticoagulant.

In the intervention group 25mM of pure vitamin C will be added to the fresh blood, and the tube will be centrifuged at around 700 RPM for 3 minutes.

The extraction socket will be filled with the corresponding graft material, and an absorbable gelatin sponge (gelfoam) will be used for socket and graft material coverage and secured using an internal crisscross knot using 5-0 monofilament polypropylene suture material.

Postoperative care and follow up:

* Patient 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.
* The patients will be advised to refrain from brushing at the surgical area for the first day after surgery.
* A soft surgical brush will be dispensed for the cleaning of the surgical area after the initial healing phase during the first 2 weeks post surgically.
* Antibiotics and analgesics will be prescribed for 5 days.
* Patients will be instructed to:

  1. Follow the instructions completely.
  2. Keep up a strict follow-up schedule.
  3. Not to touch the surgical area, with the tongue or fingers.
  4. Do not wear any kind of dental appliances, on or around the surgical site.

The sutures will be removed two weeks after the surgery. On the first day postoperatively, a baseline cone-beam computed tomography (CBCT) scan will be conducted. A final follow-up visit and CBCT scan will be scheduled for six months postoperatively.

Face to face adherence reminder session will take place to stress the post-operative instructions at the following time intervals:

* 3 days and 7 days post-operatively, for clinical assessment of swelling, wound dehiscence, and other adverse events.
* 2 weeks after the operation for follow up.
* Lastly, 6 months before implant placement.

Radiographs:

Radiographic alveolar bone changes of marginal bone loss (primary outcome), buccolingual ridge width (BLRW), buccal ridge height (BRH), and lingual ridge height (LRH) (secondary outcomes) will be assessed by an independent examiner (RW) on CBCT scans obtained at baseline and 6 months postoperatively.

Histological analysis:

For both groups (test and control), before the implant insertion, the grafted site is to be exposed and biopsies from all sites will be excised using a trephine cylindrical drill graduated to indicate the depth (from 5 to 18 mm) with abundant irrigation using sterile saline. Immediate preservation of biopsies in a 10% formalin solution, and then sent for histologic analysis to be analyzed.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria:

* ≥ 18 years of age.
* Single extraction of non-molar teeth with periodontally healthy adjacent teeth.
* Non-contributory medial history.
* Non- restorable teeth indicated for extraction.
* Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
* Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological psychological factors - time related factors).
* Cooperative patients who are willing to commit for 6 months follow up.

Exclusion Criteria:

* Pregnant female.
* Acute infection at extraction site.
* Systemic conditions affecting healing (e.g., diabetes, medications as bisphosphonates...)
* A participant who had radiotherapy or chemotherapy.
* Psychiatric patient, or with a learning disability, or unable to give consent.

Primary outcomes:
measure: Marginal bone level
timeFrame: after 6 months postoperatively.
Secondary outcomes:
measure: Buccolingual ridge width
timeFrame: after 6 months postoperatively.
measure: Buccal and lingual ridge height
timeFrame: after 6 months postoperatively.
measure: Percentage of newly formed bone
timeFrame: after 6 months postoperatively.
measure: Histological evaluation of residual graft in human biopsies
timeFrame: after 6 months postoperatively.
measure: Patient reported outcomes
timeFrame: baseline, 2 weeks, 1 month and 6 months postoperatively.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Karim fawzy, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Nesma Shemais, Lecturer
role: STUDY_CHAIR
affiliation: Cairo University
name: Noha Barwa, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: