Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
調査の概要
状態
詳細な説明
The aim of this randomised control trial is to compare the effect of wound lavage using 2.5% Ca(OCl)₂ and 2.5% NaOCl on the outcome of partial pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis (SIP).
PICO P (Population) -Mature permanent mandibular molars with carious pulpal exposure and symptomatic irreversible pulpitis (SIP).
I (Intervention) - wound lavage using 2.5% Ca(OCl)₂ C (Comparison) - wound lavage using 2.5% NaOCl O (Outcome) -
- Assessment of clinical and radiographic success at 6 and 12 months of follow up.
- Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months.
In symptomatic irreversible pulpitis (SIP), bacterial invasion of pulp tissue is common, however the inflammation is usually confined to the area adjacent to the carious lesion. It has been suggested that removal of this affected pulp tissue segment and the surrounding infected dentin can help create an environment that promote pulpal healing.
Mechanical removal of the infected pulpal tissue can be most conservatively done through partial pulpotomy (PP) where a superficial coronal inflamed pulp tissue (2-3 mm) is amputated.
PP has been proven useful in cases of irreversible pulpitis with a high success rate .This procedure is advantageous as it preserves the coronal pulp tissue and allows physiologic dentine deposition in the cervical area.
In contrast to complete pulpotomy (CP), PP removes only the superficial coronal pulp tissue, which may increase the likelihood of leaving behind affected pulp tissue.This part of the pulp, if left behind, may affect the outcome of PP. Hence, lavage with antibacterial agents in such cases may help in dissolving and disinfecting the superficial layer of the pulp wound.
Sodium hypochlorite (NaOCl) is widely used in VPT due to its antimicrobial activity, tissue-dissolving ability, and haemostatic properties. However, concerns regarding cytotoxicity, collagen degradation, compromised resin bond strength due to interference in polymerisation of composite, and handling hazards remain.
Other lavage agents such as normal saline and chlorhexidine (CHX) have shown limitations, Success of DPC following pulp wound lavage with NaOCl and saline observed significantly lower pulp survival with saline as compared to NaOCl.
CHX also exhibits dose and time- dependent cytotoxicity on fibroblastic and osteoblastic cell lines , does not dissolve organic tissue and has allergic potential .
Calcium hypochlorite [Ca(OCl)₂] has been proposed as an alternative to NaOCl owing to its comparable antimicrobial efficacy, lower cytotoxicity, minimal collagen damage, and preservation of dentin mechanical properties.
Ca(OCl)2 also releases calcium ions, suggesting a potential to promote mineralisation, this may be particularly relevant in teeth with pulp necrosis and incomplete root formation, in which REPs are indicated.
Ca(OCl)2 at 1.5% caused less structural damage to apical papilla ex vivo than NaOCl at the same concentration and had a more favourable influence on the viability, proliferation and osteogenic differentiation of human apical papilla cells(hAPCs) in vitro. Moreover, it did not impair cell chemotaxis. These findings suggest that Ca(OCl)2 may offer biological advantages in regenerative endodontic procedures.
As an endodontic irrigant, Ca(OCl)2 demonstrated organic tissue dissolution capacity .
It also provides antimicrobial effects when used as an intracanal medication for regenerative endodontics procedures, or when added to endodontic sealers .
In addition to its effective tissue dissolution capacity, calcium hypochlorite exhibits advantages such as a higher available chlorine content and a broader spectrum of microbial action.
Ca(OCl)2 showed favourable outcomes in terms of cell migration, viability, and inflammatory response .
Although evaluated as an irrigant in root canal treatment, its role as a pulpal wound lavage agent during pulpotomy has not been investigated.
This trial would help formulate evidence based clinical guidelines regarding use of calcium hypochlorite as wound lavage agent during pulpotomy.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dr. Mayank Arora, MDS
- 電話番号：+918295964200
- メール：dr.arora002@gmail.com
研究連絡先のバックアップ
- 名前：Dr. Roshni N V, PG student
- 電話番号：+919048217877
- メール：roshninv1997@gmail.com
研究場所
-
-
Haryana
-
Rohtak、Haryana、インド、124001
- 募集
- PGIDS
-
コンタクト：
- Dr. Mayank Arora, MDS
- 電話番号：+918295964200
- メール：dr.arora002@gmail.com
-
コンタクト：
- Dr. Roshni N V, MDS
- 電話番号：+919048217877
- メール：roshninv1997@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- patients aged 18-40 years
- Mature permanent mandibular molars with extremely deep caries (caries penetrating the entire thickness of the dentine radiographically, without radiopaque zone separating lesion from the pulp) and clinical diagnosis of SIP with PAI score ≤ 2
- Periodontally healthy teeth (probing pocket depth ≤3 mm and mobility within normal limit)
- Patients having physical status of class 1 or 2 according to ASA classification
- Pulpal bleeding could be controlled within 10 min following pulp amputation
Exclusion Criteria:
- Non restorable teeth
- No pulp exposure even after complete caries excavation
- Necrotic or partially necrotic pulp upon exposure
- Presence of sinus tract or soft tissue swelling
- Radiographic signs of internal or external root resorption
- Pregnant women
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Partial pulpotomy using calcium hypochlorite as wound lavage agent
Partial pulpotomy will be performed using calcium hypochlorite as wound lavage agent ,after establishing a clinical diagnosis of symptomatic irreversible pulpitis i.e. if the tooth showed symptoms triggered and lingered by cold stimuli.
|
Following pulp exposure and clinical assessment of pulp health through bleeding, the patient was randomly assigned to 2.5% Ca(OCl)₂ group.Patients who did not exhibit pulp exposure after complete caries removal, or those with partially necrotic pulp, were excluded from the study. The pulp wound was irrigated with 5 ml 2.5% Ca(OCl)₂ for 30 s. Haemostasis was achieved by placing the cotton pellets soaked with 2.5% Ca(OCl)₂ over the pulpal wound for 2 min. This process was repeated further if required, for a maximum of 10 min. Patients whose bleeding could not be arrested within 10 min had to undergo CP or pulpectomy. ProRoot MTA will be placed to a thickness of 2-3 mm gently over the pulpal tissue, a layer of RMGIC will be placed over the MTA.Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up. |
|
アクティブコンパレータ：Partial pulpotomy using sodium hypochlorite as wound lavage agent
Partial pulpotomy will be performed using sodium hypochlorite as wound lavage agent ,after establishing a clinical diagnosis of symptomatic irreversible pulpitis i.e. if the tooth showed symptoms triggered and lingered by cold stimuli.
|
Following pulp exposure and clinical assessment of pulp health through bleeding, the patient was randomly assigned to 2.5% NaOCl group.Patients who did not exhibit pulp exposure after complete caries removal, or those with partially necrotic pulp, were excluded from the study. The pulp wound was irrigated with 5 ml 2.5% NaOCl for 30 s. Haemostasis was achieved by placing the cotton pellets soaked with 2.5% NaOCl over the pulpal wound for 2 min. This process was repeated further if required, for a maximum of 10 min. Patients whose bleeding could not be arrested within 10 min had to undergo CP or pulpectomy. ProRoot MTA will be placed to a thickness of 2-3 mm gently over the pulpal tissue, a layer of RMGIC will be placed over the MTA.Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Success rate at 12 months
時間枠：12 months
|
Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment.
2. No tenderness to palpation or percussion and the tooth is functional.
3. Normal mobility and probing pocket depth.
4. Absence of associated soft tissue swelling, sinus or fistula.
Radiographic: - 1. Absence of any periapical or interradicular radiolucency.
2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al).
3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.
|
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative pain
時間枠：Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
|
Post Operative Pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line.
Score 0 means no pain and Score100 means maximum pain.
To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line.
Score 0 means no pain and Score 100 means maximum pain.
|
Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
|
|
OHRQoL assessment
時間枠：Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
|
OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.
It will be scored using a Lickert scale: never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4.
Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL
|
Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
|
協力者と研究者
捜査官
- 主任研究者：Dr Mayank Arora, MDS、PGIDS, Rohtak, 124001
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Roshni N V
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。