Treatment of Deep Carious Lesions With Selective Caries Removal, Partial or Full Pulpotomy

NCT04807244 | Unknown DMC

• 1 other identifier: EA4/249/20
• Study Type: interventional
• Target: 249
• Locations: 0 countries
• Sites: N/A

Brief Summary

The optimal treatment of deep caries lesions extended to the inner third of dentin is still under discussion. Cariologists prefer selective caries removal, meanwhile endodontists recommend partial pulpotomy. So far, no clinical trial compared both interventions against each other. Additionally, current literature indicates alternative treatment options for irreversible pulpitis besides conventional orthograde root canal treatments like the partial or full pulpotomy. Existing clinical studies on this topic were using different clinical protocols, especially with regards to the accepted time to achieve hemostasis. It is still unclear, if the pulpal bleeding time prior to the capping procedure affects the outcome of partial or full pulpotomy.

Conditions

Irreversible Pulpitis; Reversible Pulpitis; Dentine Caries

Keywords

Partial Pulpotomy; Full Pulpotomy; Selective Caries Removal

Outcome Measures

Primary Outcomes (6)

• Number of patients with positive reaction to cold testing

  Tooth sensibility with endo coldspray (-40°C) (positive or negative reaction of the patient)

  36 months

• Number of patients without mobile teeth

  Tooth mobility testing with two fingers according to the tooth mobility score (0-III)

  36 months

• Number of patients with negative reaction to palpation testing

  Palpation testing with a finger and little pressure (tenderness to palpation or no tenderness to palpation)

  36 months

• Number of patients with negative reaction to percussion testing

  Percussion testing of the treated tooth: backside of dental mirror (tenderness to percussion or no tenderness to percussion)

  36 months

• Number of patients with periodontal probing depths within normal limits

  Probing depths with a periodontal probe in mm

  36 months

• Number of Patients without clinical signs of inflammation

  Screening the oral mucosa for swelling, fistula and erythema

  36 months

Secondary Outcomes (1)

• Number of patients with a PAI score of I - II

  36 months

Study Arms (2)

Treatment of deep carious lesions: Randomized-controlled trail

OTHER

Teeth with reversible pulpitis will be included accordingly to the inclusion criteria (see below). After randomization, teeth will be treated either with selective caries removal (indirect pulp capping) or partial pulpotomy pursuant to the below described clinical protocol. The intention of this study arm is to evaluate both therapies.

Procedure: Selective Caries Removal with Biodentine™; Procedure: Partial Pulpotomy with Biodentine™; Procedure: Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomy

Treatment of deep carious lesions: Prospective non-controlled intervention trial

OTHER

Teeth with reversible pulpitis according to the inclusion criteria (see below) will be included. Depending on the clinical situation, a partial or full pulpotomy will be conducted accordingly to the defined clinical protocols (see below). In this study arm, we want to evaluate 1) different times of pulpal bleeding before pulp capping and 2) partial versus full pulpotomy on the clinical outcome in teeth with irreversible pulpitis.

Procedure: Full Pulpotomy with Biodentine™; Procedure: Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomy

Interventions

Selective Caries Removal with Biodentine™ PROCEDURE

1. Rubber dam placement 2. Cleaning of the tooth and rubber dam with ethanol 98% 3. Caries removal: Removal of protruding parts of enamel/dentin with high-speed round bur with continuous water cooling, caries removal with a low-speed round bur; peripheral caries is removed until only hard dentin is left, while the pulp wall is excavated until reaching leathery dentin 4. Disinfection of the leathery dentin 5 ml 1% NaOCl (speed: 1 ml per min) 5. Indirect pulp capping (layer of 1-2 mm) of the carious lesion with Biodentine™ (15 min setting time after mixing)

Treatment of deep carious lesions: Randomized-controlled trail

Partial Pulpotomy with Biodentine™ PROCEDURE

1. Rubber dam placement 2. Cleaning of the tooth and rubber dam with ethanol 98% 3. Caries removal: Removal of protruding parts of enamel/dentin with high-speed round bur with continuous water cooling, caries removal with a low-speed round bur; before accessing the pulp chamber, the central caries will be left, peripheral caries will be excavated completely 4. Disinfection of the leathery dentin 5 ml NaOCl 1% (speed: 1 ml per min) 5. Accessing the pulp chamber with a high-speed round bur and removal of 2-3 mm pulp tissue; irrigation with 2 ml NaOCl 1% 6. Hemostasis will be achieved with a sterile foam pellet soaked with NaOCl 1% with gentle pressure to the pulp for 3 min 7. If hemostasis could not be achieved within 3 min, step 6 will be repeated once. In case of no hemostasis, transfer of the case to Intervention: "full pulpotomy with Biodentine" 8. Confirmed hemostasis: pulp capping with Biodentine™ (layer min. 2-3 mm, 15 min setting time after mixing)

Treatment of deep carious lesions: Randomized-controlled trail

Full Pulpotomy with Biodentine™ PROCEDURE

1. Rubber dam placement 2. Cleaning of the tooth and rubber dam with ethanol 98% 3. Caries removal: Removal of protruding parts of enamel/dentin with high-speed round bur with continuous water cooling, caries removal with a low-speed round bur; before accessing the pulp chamber, the central caries will be left, peripheral caries will be excavated completely 4. Disinfection of the leathery dentin 5 ml NaOCl 1% (speed: 1 ml per min) 5. Accessing the pulp chamber with a high-speed round bur and removal of the entire pulp chamber roof; full pulpotomy to stump level with a high-speed round bur under continuous irrigation with 5 ml NaOCl 1% 6. Hemostasis will be achieved with a sterile foam pellet soaked with NaOCl 1% with gentle pressure to the pulp for 3 min 7. If hemostasis could not be achieved within 3 min, step 6 will be repeated once. In case of no hemostasis, exclusion. 8. Confirmed hemostasis: pulp capping with Biodentine™ (layer min. 2-3 mm, 15 min setting time after mixing)

Treatment of deep carious lesions: Prospective non-controlled intervention trial

Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomy PROCEDURE

1. Dentin cleaning with a low-speed round bur 2. Use of Scotchbond Universal™ and Filtek Supreme XTE™ according to manufacturer's recommendation

Treatment of deep carious lesions: Prospective non-controlled intervention trial; Treatment of deep carious lesions: Randomized-controlled trail

Eligibility Criteria

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

You may qualify if:

• Age \> 18 a Health status
• No contributory systemic diseases with influence to the immune system or coagulation system
• Tooth-related factors
• Type: Permanent molars
• Mature roots
• Caries extended to \>2/3 of dentin and expected pulp exposure performing non-selective caries removal (Only study arm "partial pulpotomy": Pulp exposure after non-selective caries removal)
• Sensibility: +/++; prolonged \<5s
• Pain only on stimulus (hot/cold) and not prolonged or no pain
• No tenderness to palpation
• No tenderness to percussion
• Periodontal probing depth \<4 mm
• No pathologic tooth mobility
• No swelling
• No fistula
• No swelling

You may not qualify if:

• Age \< 18 a
• Health status with above mentioned contributory diseases (immunosuppression, or diseases related to the coagulation system)
• Deciduous teeth
• Immature roots
• Caries extending less than \<2/3 of dentin
• (Only study arm "partial pulpotomy": No pulp exposure after non-selective caries removal)
• Tooth sensibility +++ or prolonged \> 5 s
• Severe pain, prolonged on stimulus (hot/cold), dull, throbbing, spontaneous pain
• Tenderness to palpation +
• Periodontal probing depth \>3 mm
• Tooth mobility grade \>Score I
• Swelling present
• Fistula present
• Radiograph: Apical periodontitis or apical rarefaction
• Partial or full crown restauration in situ

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Septodont: collaborator
• 3M: collaborator

Related Publications (15)

• Adl A, Javanmardi S, Abbaszadegan A. Assessment of tooth discoloration induced by biodentine and white mineral trioxide aggregate in the presence of blood. J Conserv Dent. 2019 Mar-Apr;22(2):164-168. doi: 10.4103/JCD.JCD_466_18.

  PMID: 31142987 BACKGROUND

• Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.

  PMID: 30292451 BACKGROUND

• Duncan HF, Bjorndal L, van der Sluis L, Rechenberg DK, Simon S, Cooper PR, Ricucci D, Galler K. Third European Society of Endodontology (ESE) research meeting: ACTA, Amsterdam, The Netherlands, 26th October 2018: Deep caries and the exposed pulp: current and emerging therapeutic perspectives. Int Endod J. 2019 Feb;52(2):135-138. doi: 10.1111/iej.13059. No abstract available.

  PMID: 30644590 BACKGROUND

• Burke FJT, Crisp RJ, Cowan AJ, Raybould L, Redfearn P, Sands P, Thompson O, Ravaghi V. A Randomised Controlled Trial of a Universal Bonding Agent at Three Years: Self Etch vs Total Etch. Eur J Prosthodont Restor Dent. 2017 Dec 1;25(4):220-227. doi: 10.1922/EJPRD_01692Burke08.

  PMID: 29182212 BACKGROUND

• Camilieri J (2015) Mineral trioxide aggregate: present and future developments Endodontic Topics Volume 31, 31-46.

  BACKGROUND

• de Paris Matos T, Perdigao J, de Paula E, Coppla F, Hass V, Scheffer RF, Reis A, Loguercio AD. Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. Dent Mater. 2020 Nov;36(11):1474-1485. doi: 10.1016/j.dental.2020.08.007. Epub 2020 Sep 12.

  PMID: 32933775 BACKGROUND

• Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.

  PMID: 29061359 BACKGROUND

• Haak R, Hahnel M, Schneider H, Rosolowski M, Park KJ, Ziebolz D, Hafer M. Clinical and OCT outcomes of a universal adhesive in a randomized clinical trial after 12 months. J Dent. 2019 Nov;90:103200. doi: 10.1016/j.jdent.2019.103200. Epub 2019 Sep 25.

  PMID: 31562889 BACKGROUND

• Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.

  PMID: 26231300 BACKGROUND

• Linsuwanont P, Wimonsutthikul K, Pothimoke U, Santiwong B. Treatment Outcomes of Mineral Trioxide Aggregate Pulpotomy in Vital Permanent Teeth with Carious Pulp Exposure: The Retrospective Study. J Endod. 2017 Feb;43(2):225-230. doi: 10.1016/j.joen.2016.10.027. Epub 2016 Dec 29.

  PMID: 28041685 BACKGROUND

• Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.

  PMID: 3457698 BACKGROUND

• Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.

  PMID: 29397003 BACKGROUND

• Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.

  PMID: 28673494 BACKGROUND

• Uesrichai N, Nirunsittirat A, Chuveera P, Srisuwan T, Sastraruji T, Chompu-Inwai P. Partial pulpotomy with two bioactive cements in permanent teeth of 6- to 18-year-old patients with signs and symptoms indicative of irreversible pulpitis: a noninferiority randomized controlled trial. Int Endod J. 2019 Jun;52(6):749-759. doi: 10.1111/iej.13071. Epub 2019 Jan 30.

  PMID: 30638262 BACKGROUND

• Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.

  PMID: 28776717 BACKGROUND

MeSH Terms

Interventions

tricalcium silicate

Study Officials

• Falk Schwendicke, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Central Study Contacts

Sascha R Herbst, Dr.

CONTACT

450662697; sascha.herbst@charite.de

Falk Schwendicke, Prof.

CONTACT

450562556; falk.schwendicke@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Every patient has to give informed consent for participating in one of both study arms. To avoid clustering, only one tooth per patient can be included. Arm A is designed as a randomized-controlled and arm B as a non-controlled intervention trial. The intervention in study arm B will be conducted adapted to the clinical findings after entering slightly the pulp chamber. Depending on the pulpal bleeding time, either a partial pulpotomy or a full pulpotomy will be conducted, according to the predefined protocol mentioned in "treatment protocol for arm A". Due to the experimental design, only single blinding of the patient is feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department for Oral Diagnostics, Digital Health and Health Services Research

Model Details: Randomized Controlled Trial and Prospective Non-controlled Intervention Trial

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 19, 2021
• Study Start: April 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2025
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share