Wound Healing with Hyaluronic Acid After Alveolar Ridge Preservation

NCT04467736 | Completed

• 1 other identifier: BC-07718
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

After tooth extraction, shrinkage of the bone is expected after 6 months. These changes may hamper dental implant placement and compromise soft tissue aesthetics. Alveolar Ridge Preservation (ARP) includes application of bovine-derived deproteinized bone particles in the extraction site. This technique is widely performed and drastically limits aforementioned volumetric changes. The amount of bone preservation following ARP is affected by the soft tissue barrier. In an open healing situation, it takes about 4 weeks to have complete soft tissue closure. Faster soft tissue closure could optimize the amount of bone preservation with obvious benefits for implant placement and aesthetics. Recent presentations showed the application of hyaluronic acid after ARP. However, no evidence can be found in the literature. This study aims to evaluate the wound healing potential of hyaluronic acid following ARP, as this has never been performed, yet seems promising from a biological point of view.

Conditions

Healing Wound

Keywords

Alveolar ridge preservation; Hyaluronic acid; Wound healing

Outcome Measures

Primary Outcomes (1)

• Wound reduction

  performed by measuring the maximum mesio-distal and bucco-oral dimension of the wound immediately after ARP and after 21 days

  Week 3 after ARP

Secondary Outcomes (9)

• Compliance

  Week 1

• Number of painkillers consumed

  Week 1

• VAS pain

  Week 1

• VAS swelling

  Week 1

• Bleeding

  Week 1

Study Arms (2)

Control

NO INTERVENTION

No further treatment after alveolar ridge preservation

Test

ACTIVE COMPARATOR

In case the test group comes out, instructions for the daily application of hyaluronic acid (Gengigel Forte©) will be given. Hyaluronic acid will be administered by the patient 3 times per day during 7 days.

Device: Gengigel Forte©

Interventions

Gengigel Forte© DEVICE

Gengigel (hyaluronic acid) will be administered by the patient 3 times per day during 7 days following alveolar ridge preservation

Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old;
• Good oral hygiene defined as a full-mouth plaque score ≤25%;
• One or two neighboring teeth;
• Need for ARP after tooth extraction with \>50% buccal bone still present

You may not qualify if:

• Systemic diseases;
• Smoking;
• (History) of periodontal disease;
• Untreated caries lesions

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital

Ghent, 9000, Belgium

Location

Related Publications (14)

• Afat IM, Akdogan ET, Gonul O. Effects of Leukocyte- and Platelet-Rich Fibrin Alone and Combined With Hyaluronic Acid on Pain, Edema, and Trismus After Surgical Extraction of Impacted Mandibular Third Molars. J Oral Maxillofac Surg. 2018 May;76(5):926-932. doi: 10.1016/j.joms.2017.12.005. Epub 2017 Dec 13.

  PMID: 29304325 BACKGROUND

• Afat IM, Akdogan ET, Gonul O. Effects of leukocyte- and platelet-rich fibrin alone and combined with hyaluronic acid on early soft tissue healing after surgical extraction of impacted mandibular third molars: A prospective clinical study. J Craniomaxillofac Surg. 2019 Feb;47(2):280-286. doi: 10.1016/j.jcms.2018.11.023. Epub 2018 Dec 3.

  PMID: 30579747 BACKGROUND

• Cosyn J, Cleymaet R, De Bruyn H. Predictors of Alveolar Process Remodeling Following Ridge Preservation in High-Risk Patients. Clin Implant Dent Relat Res. 2016 Apr;18(2):226-33. doi: 10.1111/cid.12249. Epub 2014 Jul 17.

  PMID: 25041378 BACKGROUND

• Eskandarinia A, Kefayat A, Gharakhloo M, Agheb M, Khodabakhshi D, Khorshidi M, Sheikhmoradi V, Rafienia M, Salehi H. A propolis enriched polyurethane-hyaluronic acid nanofibrous wound dressing with remarkable antibacterial and wound healing activities. Int J Biol Macromol. 2020 Apr 15;149:467-476. doi: 10.1016/j.ijbiomac.2020.01.255. Epub 2020 Jan 27.

  PMID: 32001284 BACKGROUND

• Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.

  PMID: 22211307 BACKGROUND

• Litwiniuk M, Krejner A, Speyrer MS, Gauto AR, Grzela T. Hyaluronic Acid in Inflammation and Tissue Regeneration. Wounds. 2016 Mar;28(3):78-88.

  PMID: 26978861 BACKGROUND

• Neuman MG, Nanau RM, Oruna-Sanchez L, Coto G. Hyaluronic acid and wound healing. J Pharm Pharm Sci. 2015;18(1):53-60. doi: 10.18433/j3k89d.

  PMID: 25877441 BACKGROUND

• Seyssens L, Eghbali A, Christiaens V, De Bruyckere T, Doornewaard R, Cosyn J. A one-year prospective study on alveolar ridge preservation using collagen-enriched deproteinized bovine bone mineral and saddle connective tissue graft: A cone beam computed tomography analysis. Clin Implant Dent Relat Res. 2019 Oct;21(5):853-861. doi: 10.1111/cid.12843. Epub 2019 Aug 28.

  PMID: 31456345 BACKGROUND

• Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.

  PMID: 22211303 BACKGROUND

• Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.

  PMID: 19929956 BACKGROUND

• Wessels R, De Roose S, De Bruyckere T, Eghbali A, Jacquet W, De Rouck T, Cosyn J. The Mucosal Scarring Index: reliability of a new composite index for assessing scarring following oral surgery. Clin Oral Investig. 2019 Mar;23(3):1209-1215. doi: 10.1007/s00784-018-2535-6. Epub 2018 Jul 3.

  PMID: 29971512 BACKGROUND

• Yildirim S, Ozener HO, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105.

  PMID: 28914592 BACKGROUND

• Zeltner M, Jung RE, Hammerle CH, Husler J, Thoma DS. Randomized controlled clinical study comparing a volume-stable collagen matrix to autogenous connective tissue grafts for soft tissue augmentation at implant sites: linear volumetric soft tissue changes up to 3 months. J Clin Periodontol. 2017 Apr;44(4):446-453. doi: 10.1111/jcpe.12697. Epub 2017 Feb 11.

  PMID: 28107560 BACKGROUND

• Eeckhout C, Ackerman J, Glibert M, Cosyn J. A randomized controlled trial evaluating hyaluronic acid gel as wound healing agent in alveolar ridge preservation. J Clin Periodontol. 2022 Mar;49(3):280-291. doi: 10.1111/jcpe.13589. Epub 2021 Dec 30.

  PMID: 34961942 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly allocated to the 'test group (Hyaluronic acid)' or the 'control group (No hyaluronic acid). An equal number of sealed envelopes will be prepared internally labelled as 'test group' or 'control group'. Just after alveolar ridge preservation, a sealed envelope will be randomly selected and opened to reveal further treatment. The measuring investigator will not be involved in the treatment of any of the patients and will be blinded to allow unbiased registrations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: August 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: January 24, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)