Primary Teeth Pulp Capping Material

Active, not recruiting

• Conditions: Pulpitis,

• Registration Number: CTRI/2023/09/057966
• Lead Sponsor: Dr. Daya Srinivasan

Brief Summary

The study after IHEC(Institutional Human Ethical Committee) approval and registered in the clinical trial registry and will follow CONSORT guidelines. Parental consent, Child’s assent will be taken before start of the study.

**Study Setting/ Demographics**

It will be a single-center; double-blinded Randomised contolled trial. Children between 4-7 years of both the genders who require Indirect pulpal treatment on primary lower second molars following a split mouth study design will be included in the study.

**Inclusion criteria**:

1. Healthy patients aged 4–7 years with previously untreated lower second primary molars in cooperative children with good general health.

2. Children having had deep dentin caries involving occlusal and or occlusoproximal surfaces.

3. Children who were radiographically detected with caries penetration involving approximately 3/4 of the dentin thickness.

4. Children who were considered to have a potential to result in pulp exposure when the entire caries was cleared according to the complete excavation procedure in which the end point of carious tissue removal is the hard dentin.

5. Children whose teeth showed a moderate response to chemical and thermal stimuli.

Exclusion criteria:

1. Teeth showing signs of irreversible pulpitis (such as spontaneous pain, prolonged pain response)

2. Teeth showing pathological mobility,

3. Teeth showing infectious symptoms such as fistula or abscess, and discoloration

4. Presence of radiolucency in the furcation or periapical regions, and internal or external root resorption.

5.          Children with systemic problems, congenital abnormalities and special children.

**Sample size:** G power software: t tests - Means: Difference between two independent means (two groups)

Analysis: A priori: Compute required sample size

Input: Tail(s)                        = One

Effect size d                  = 0.5

α err prob                     = 0.05

Power (1-β err prob)           = 0.85

Allocation ratio N2/N1         = 1

Output: Noncentrality parameter δ      = 2.7156951

Critical t                     = 1.6580957

Df                             = 116

Sample size group 1            = 59

Sample size group 2            = 59

Total sample size              = 118

Actual power                   = 0.8542756

To account for attrition, 18 is added to calculated sample size. Thus the final sample size is 136 .  It accounts to **68 pairs in a split mouth design.**

**Methodology:** Following the clinical and radiographic examinations, children will be selected based on the selection criteria. After rubber-dam isolation, cavity preparation will be performed and the caries will be removed using a high-speed dental handpiece with a NO 2 round diamond bur with copious irrigation. The carious peripheral dentin will be removed at the enamel–dentin junction along with the infected and necrotic soft dentin layer in the centre. Cavity excavation will be stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation, and the demineralized dentin (affected dentin) will be left on the floor of the cavity. This procedure until the caries removal will be common for both groups;

Group 1: SDF (test group) The entire residual demineralized dentin will be covered with a thin layer SDF (Kids-e Dental E  38% SDF) in accordance with the recommendations of the manufacturer.

Group 2: Biodentine (Control group) A thin layer of tricalcium silicate containing pulp-capping material (approximately 1 mm) (Biodentine, Septodont, Saint-Maur-des-Fossés, France) consisting of powder and liquid will be applied to the entire residual demineralized dentin tissue and a 12-min setting time will be allowed for setting, in accordance with the recommendations of the manufacturer.

After the placement of pulp capping agent in both the groups a thin layer of Glass Ionomer Cement (GIC) base will be given without involving the enamel margins and finally will be restored with composite restoration.

The Radiovisuography using paralleling technique will be taken during recall visit using Cone positioner to standardize the radiographs.

**Histological (exvivo):**

Inclusion Criteria: Children undergoing serial extraction procedure requiring extraction of primary molars.

Exclusion: Children who have congenitally missing teeth,

Children with developmental anomalies, systemic disturbances, Children/parents not willing to participate in the study.

**G power software:**

t tests - Means: Difference between two independent means (two groups)

Analysis: A priori: Compute required sample size

Input: Tail(s)                        = One

Effect size d                  = 0.5

α err prob                     = 0.5

Power (1-β err prob)           = 0.85

Allocation ratio N2/N1         = 1

Output: Noncentrality parameter δ      = 1.0606602

Critical t                     = 6.742454e-17

Df                             = 16

Sample size group 1            = 9

Sample size group 2            = 9

**Total sample size****=****18**

Actual power                   = 0.8555778

Teeth which will be selected for histopathological evaluation will be receiving the respective pulp capping agent after preparing a cavity intentionally approximating without involving the pulp and be followed for 6 months period. After 6 months the teeth will be extracted and will be fixed in 10% formaldehyde solution. The specimens will be then prepared for  Bucco-lingual sectioning and will be examined under light microscopy based on the parameters evaluated in previous studies by Ricucci D et al.

EXPECTED OUTCOME :

**Clinical criteria:**The tooth will be evaluated for presence / absence of  pain, swelling, tender on percussion, pathological mobility and gingival sinus tract opening or purulent discharge for at 3, 6, 9, 12, 18 and 24  months

**Radiographic criteria:**The tooth will be evaluated for presence /absence of radiographic radiolucency pathologically, presence furcal involvement, peri apical radiolucency and internal or external resorption. The increase in dentin thickness will be measured using care stream software attached to Radiovisuography keeping cement-enamel junction as a reference point.

**Histological criteria**:Pulpal inflammation, prescence of tertiary dentin, Odontoblastic integrity will be evaluated based on Ricucci et al criteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-16
• Last Update Posted: 2024-10-06

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Children aged 4–7 years with previously untreated lower second primary molars in cooperative children with good general health.
• Children having had deep dentin caries involving occlusal and or occlusoproximal surfaces.
• Children who were radiographically detected with caries penetration involving approximately 3/4 of the dentin thickness.
• Children who were considered to have a potential to result in pulp exposure when the entire caries was cleared according to the complete excavation procedure in which the end point of carious tissue removal is the hard dentin.
• Children whose teeth showed a moderate response to chemical and thermal stimuli.

Exclusion Criteria

• 1.Teeth showing signs of irreversible pulpitis (such as spontaneous pain, prolonged pain response) 2.Teeth showing pathological mobility, 3.Teeth showing infectious symptoms such as fistula or abscess, and discoloration 4.Presence of radiolucency in the furcation or periapical regions, and internal or external root resorption.
• 5.Children with systemic problems, congenital abnormalities and special children.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical criteria: Tooth evaluated for presence / absence of pain, swelling, tender on percussion, pathological mobility & gingival sinus tract opening or purulent discharge Radiographic criteria: Evaluated for radiographic radiolucency , furcal involvement, peri apical radiolucency and internal or external resorption. The increase in dentin thickness will be measured using care stream software attached to Radiovisuography keeping cement-enamel junction as a reference .	3, 6,9,12,18, 24 months

Secondary Outcome Measures

Name	Time	Method
Histological criteria:Pulpal inflammation, prescence of tertiary dentin, Odontoblastic integrity will be evaluated.

Trial Locations

Locations (1)

Chettinad Dental College and Research Institute; 🇮🇳 Kancheepuram, TAMIL NADU, India

Chettinad Dental College and Research Institute

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Daya Srinivasan

Principal investigator

9884476385

dayaswathi@gmail.com